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NCT06909565RecruitingPhase 4

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
6000 (estimated)
First submitted
27 Mar 2025
Start date
23 Jul 2025
Primary completion date
Oct 2029
Lead sponsor
Duke University
NCT number
NCT06909565

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 6000
  • From 23 Jul 2025 to the primary completion date, Oct 2029
  • 149 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or planned use of an open-label PCSK9 inhibitor during the study
  • Any prior treatment with inclisiran
  • Active or planned participation in another clinical study involving investigational drugs or devices during the study
  • Patients taking prohibited therapies as listed in Section 6.6.3

Other illness

  • Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results

Other

  • Planned future PCI or PVI
  • Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities
  • Pregnant or breast-feeding women

Who the study is looking for

  • Signed informed consent must be obtained prior to participation in the study.
  • Males or females ≥ 18 years of age
  • Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD
  • Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (149)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Capital Cardiology Associates
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AlbanyUnited StatesRecruiting
Presbyterian Heart Group
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AlbuquerqueUnited StatesRecruiting
Advanced Cardiovascular, LLC
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Alexander CityUnited StatesRecruiting
PharmaTex Research
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AmarilloUnited StatesRecruiting
Amarillo Heart Clinical Research Institute, Inc.
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AmarilloUnited StatesRecruiting
AnMed Health Medical Center
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AndersonUnited StatesRecruiting
Asheville Cardiology Associates Research Department
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AshevilleUnited StatesRecruiting
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesRecruiting
Austin Heart
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AustinUnited StatesRecruiting
IMS Cardiology
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AvondaleUnited StatesRecruiting
Northern Light Eastern Maine Medical Center
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BangorUnited StatesRecruiting
St. Luke's University Health Network
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BethlehemUnited StatesRecruiting
Pacific Oaks Medical Group
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Beverly HillsUnited StatesRecruiting
Cardiology, PC
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BirminghamUnited StatesRecruiting
Grace Research LLC
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Bossier CityUnited StatesRecruiting
Bridgeport Hospital
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BridgeportUnited StatesRecruiting
Advanced Heart Care LLC
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BridgewaterUnited StatesRecruiting
Sisters of Charity Hospital
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BuffaloUnited StatesRecruiting
Trinity Medical WNY, PC
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BuffaloUnited StatesRecruiting
Capital Area Research, LLC
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Camp HillUnited StatesRecruiting
Aultman Hospital
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CantonUnited StatesRecruiting
Wellspan Chambersburg Hospital
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ChambersburgUnited StatesRecruiting
Novant Health Clinical Research/Heart & Vascular Institute
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CharlotteUnited StatesRecruiting
Mecklenburg Heart Specialists
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CharlotteUnited StatesRecruiting
University of Illinois Chicago
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ChicagoUnited StatesRecruiting
Cardiovascular Institute of San Diego
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Chula VistaUnited StatesRecruiting
Baycare Medical Group
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ClearwaterUnited StatesRecruiting
Clearwater Cardiovascular Consultants
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ClearwaterUnited StatesRecruiting
Medstar Southern Maryland Hospital Center
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ClintonUnited StatesRecruiting
University of Missouri Health Care
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ColumbiaUnited StatesRecruiting
John Muir Medical Center-Concord Campus
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ConcordUnited StatesRecruiting
Javara inc.
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ConroeUnited StatesWithdrawn
Pioneer Clinical Studies
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Coral GablesUnited StatesRecruiting
Valley Clinical Trials
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CovinaUnited StatesWithdrawn
Louisiana Heart Center
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CovingtonUnited StatesRecruiting
Nuvance Health-Danbury Hospital
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DanburyUnited StatesRecruiting
Cardiology Research Associates
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Daytona BeachUnited StatesRecruiting
Arrow Clinical Trails
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Daytona BeachUnited StatesRecruiting
Essentia Health-SMMC
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DuluthUnited StatesRecruiting
Aspirus Saint Luke's Hospital
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DuluthUnited StatesRecruiting
Midwest Cardiovascular Research and Education Foundation
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ElkhartUnited StatesRecruiting
Cardiovascular Associates of the Delaware Valley
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ElmerUnited StatesRecruiting
Aurora Denver Cardiology Associates - Englewood
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EnglewoodUnited StatesRecruiting
Javara Inc.
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FayettevilleUnited StatesRecruiting
Advanced Heart and Vascular Institute of Hunterdon
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FlemingtonUnited StatesRecruiting
Northeast Georgia Heart Center, PC
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GainesvilleUnited StatesRecruiting
Stern Cardiovascular Center
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GermantownUnited StatesRecruiting
Thrive Clinical Research Group
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GlendoraUnited StatesRecruiting
CHI Health Nebraska Heart
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Grand IslandUnited StatesRecruiting
Bellin Memorial Hospital
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Green BayUnited StatesRecruiting
Ballad Health System
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GreenevilleUnited StatesRecruiting
Moses H Cone Memorial Hospital
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GreensboroUnited StatesRecruiting
Cardiovascular Associates of the Delaware Valley
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Haddon HeightsUnited StatesRecruiting
Wake Forest University Health Sciences
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High PointUnited StatesRecruiting
Texas Heart Institute
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HoustonUnited StatesRecruiting
Vital Heart and Vein
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HumbleUnited StatesRecruiting
Heart Center Research, LLC
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HuntsvilleUnited StatesRecruiting
The Jackson Clinic, PA
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JacksonUnited StatesRecruiting
Apex Research Foundation, LLC
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JacksonUnited StatesRecruiting
First Coast Cardiovascular Institute PA
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JacksonvilleUnited StatesRecruiting
UF Health Jacksonville
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JacksonvilleUnited StatesRecruiting
Cardiology Associates Research Group
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JonesboroUnited StatesRecruiting
Texas Cardiology Associates of Houston
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KingwoodUnited StatesRecruiting
Penn Lancaster General Health Research Institute
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LancasterUnited StatesRecruiting
Capitol Cardiology Associates PA
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LanhamUnited StatesRecruiting
UMH-Sparrow Clinical Research Institute
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LansingUnited StatesRecruiting
McLaren Center for Research and Innovation
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LansingUnited StatesRecruiting
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
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LargoUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesRecruiting
Bryan Heart
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LincolnUnited StatesRecruiting
CHI Health Nebraska Heart
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LincolnUnited StatesRecruiting
Arkansas Heart Hospital
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Little RockUnited StatesRecruiting
Arkansas Cardiology
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Little RockUnited StatesRecruiting
Heart Institute of East Texas
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LufkinUnited StatesRecruiting
JAVARA Inc, - Mankato Clinic
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MankatoUnited StatesRecruiting
DHR Health Institute for Research
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McAllenUnited StatesRecruiting
Heart Center of Lake County
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MerrillvilleUnited StatesRecruiting
Inpatient Research Clinic LLC
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Miami LakesUnited StatesRecruiting
MyMichigan Medical Center Midland
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MidlandUnited StatesRecruiting
Aurora Saint Luke's Medical Center
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MilwaukeeUnited StatesRecruiting
Duke Cardiology
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MorrisvilleUnited StatesRecruiting
Intermountain Medical Center
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MurrayUnited StatesRecruiting
TriStar Centennial Medical center
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NashvilleUnited StatesRecruiting
Tulane School of Medicine
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New OrleansUnited StatesRecruiting
Radin Cardiovascular Medical Group, Inc
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Newport BeachUnited StatesRecruiting
TPMG Clinical Research
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Newport NewsUnited StatesRecruiting
Mount Sinai School of Medicine
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New YorkUnited StatesRecruiting
Sentara Norfolk General Hospital
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NorfolkUnited StatesRecruiting
Valley Clinical Trials, LLC - Flourish Research
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NorthridgeUnited StatesRecruiting
Amicis Research
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NorthridgeUnited StatesRecruiting
South Oklahoma Heart Research LLC
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Oklahoma CityUnited StatesRecruiting
Methodist Physicians Clinic Heart Consultants
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OmahaUnited StatesRecruiting
Midwest Heart and Vascular Specialists
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Overland ParkUnited StatesRecruiting
Research Integrity LLC
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OwensboroUnited StatesRecruiting
Cardiovascular Institute of Northwest Florida
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Panama CityUnited StatesRecruiting
Gulf Coast Heart and Vascular
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Panama CityUnited StatesRecruiting
Advocate Aurora Lutheran General Hospital
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Park RidgeUnited StatesRecruiting
Javara, Inc.
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Peachtree CityUnited StatesWithdrawn
OSF Multi-Specialty Group
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PeoriaUnited StatesRecruiting
AtlantiCare Regional Medical Center
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PomonaUnited StatesRecruiting
Trinity Health Oakland Hospital
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PontiacUnited StatesRecruiting
Charlotte Heart & Vascular Center, PA
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Port CharlotteUnited StatesRecruiting
Hudson Valley Cardiovascular Practice PC
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PoughkeepsieUnited StatesRecruiting
MultiCare Institute for Research and Innovation
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PuyallupUnited StatesRecruiting
Duke Vascular Surgery and Vein Center at Brier Creek
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RaleighUnited StatesRecruiting
Monument Health Clinical Research
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Rapid CityUnited StatesRecruiting
Chippenham Hospital
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RichmondUnited StatesRecruiting
Reid Physician Associates
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RichmondUnited StatesRecruiting
Riverside Community Hospital
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RiversideUnited StatesRecruiting
University of Rochester Medical Center
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RochesterUnited StatesRecruiting
Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
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Rochester HillsUnited StatesRecruiting
OSF HealthCare Cardiovascular Institute
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RockfordUnited StatesRecruiting
Shady Grove Adventist Hospital
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RockvilleUnited StatesRecruiting
Austin Heart PLLC
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Round RockUnited StatesRecruiting
Clearwater Cardiovascular Consultants
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Safety HarborUnited StatesActive, not recruiting
TidalHealth Peninsula Regional
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SalisburyUnited StatesRecruiting
San Diego Cardiac Center
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San DiegoUnited StatesRecruiting
Kaiser Permanente - San Diego
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San DiegoUnited StatesRecruiting
Sutter Health Heart and Vascular
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San FranciscoUnited StatesRecruiting
Austin Heart
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San MarcosUnited StatesRecruiting
Cardiovascular Associates of the Delaware Valley
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SewellUnited StatesRecruiting
Cardiovascular Solutions LLC
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ShreveportUnited StatesRecruiting
Jadestone Clinical Research, LLC
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Silver SpringUnited StatesRecruiting
Stern Cardiovascular
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SouthavenUnited StatesRecruiting
Heart House Research Foundation LLC
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SpringfieldUnited StatesRecruiting
Cardiology Associates of Fairfield County
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StamfordUnited StatesRecruiting
Richmond University Medical Center
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Staten IslandUnited StatesRecruiting
MultiCare Institute for Research and Innovation
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TacomaUnited StatesRecruiting
Washington Vascular Specialists - ClinRe 001-136
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Takoma ParkUnited StatesRecruiting
Tampa Cardiovascular Interventions and Research
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TampaUnited StatesRecruiting
Jacobi Medical Center
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The BronxUnited StatesRecruiting
ClinRe 001-001
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ThorntonUnited StatesRecruiting
ProMedica Toledo Hospital
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ToledoUnited StatesRecruiting
Viva Heart and Vein
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TomballUnited StatesRecruiting
Northwest Houston Heart Center
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TomballUnited StatesRecruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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TorranceUnited StatesRecruiting
Atlanta Heart Specialists LLC
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TuckerUnited StatesRecruiting
Cardiology Associates of North Mississippi
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TupeloUnited StatesRecruiting
The Heart Medical Group
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Van NuysUnited StatesRecruiting
FOMAT - West Coast Research Center
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VenturaUnited StatesRecruiting
Iowa Heart Center
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West Des MoinesUnited StatesRecruiting
Interventional Cardiology Medical Group
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West HillsUnited StatesRecruiting
Monroe Research, LLC
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West MonroeUnited StatesRecruiting
Cardiology Associates of West Reading
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West ReadingUnited StatesRecruiting
Kansas Nephrology Physicians, PA
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WichitaUnited StatesRecruiting
Winchester Cardiology and Vascular Medicine
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WinchesterUnited StatesRecruiting
Novant Health Forsyth Medical Center
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Winston-SalemUnited StatesRecruiting
WellSpan Heart and Vascular Research
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YorkUnited StatesRecruiting
Genesis HealthCare System
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ZanesvilleUnited StatesRecruiting

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