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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes

A legfontosabb adatok

Ki végzi
Baylor Research Institute
Hol
Atlanta, Austin, Boston, Chicago, Cleveland, Corpus Christi, Dallas, Davenport, Denver, Detroit, El Paso, Kingsport, Little Rock, McKinney, Muncie, New Bern, Oklahoma City, Philadelphia, San Antonio és St Louis (Egyesült Államok)Mind a 24 helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
14 000 fő, tervezett
Kezdés
2013. jan.
Várható befejezés
2033. jan.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A regiszteradat frissítve
2026. február 6.

Ki vehet részt

Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 3 feltétel megnézéseKevesebb

Ki vehet részt

  • Underwent Endovascular Intervention
  • Treated Iliac, Common or Superficial Femoral, Popliteal, Peroneal, Anterior Tibial, or Posterior Tibial Arteries

Ki nem vehet részt

  • Surgical Bypass

Helyszínek itt: Egyesült Államok

  • Emory UniversityAtlanta, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Seton Heart Institute/ UT AustinAustin, Egyesült ÁllamokContact: Sarah J BenedictRésztvevőt keres
  • Cardiothoracic and Vascular SurgeonsAustin, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • VA Boston Healthcare SystemBoston, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Loyola University Medical CenterChicago, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Cleveland ClinicCleveland, Egyesült ÁllamokContact: Aravinda Nanjundappa, MD (principal investigator)Résztvevőt keres
  • Harrington Heart and Vascular Institute, University HospitalsCleveland, Egyesült ÁllamokContact: Mehdi Shishehbor, MD (principal investigator)Résztvevőt keres
  • Christus Sphon Hospital Corpus Christi-ShorelineCorpus Christi, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Baylor Scott & White Research InstituteDallas, Egyesült ÁllamokContact: David Fernandez Vazquez, MDRésztvevőt keres
  • North Texas Veteran Affairs Medical CenterDallas, Egyesült ÁllamokContact: Shirling Tsai, MD (principal investigator)Résztvevőt keres
  • Mid West Cardiovascular Research FoundationDavenport, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Denver VAMCDenver, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Detroit Medical CenterDetroit, Egyesült ÁllamokContact: Chadi Alraies, MD (principal investigator)Résztvevőt keres
  • El Paso Cardiovascular CareEl Paso, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Wellmont CVA Heart InstituteKingsport, Egyesült ÁllamokContact: Gaurav Rana, MD (principal investigator)Résztvevőt keres
  • Arkansas Heart InstituteLittle Rock, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • North Dallas Research AssociatesMcKinney, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Indiana University Health Ball Memorial HospitalMuncie, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Carolina East Health SystemNew Bern, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Integris Heart HospitalOklahoma City, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Oklahoma University Health Science CenterOklahoma City, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • Albert Einstein Healthcare NetworkPhiladelphia, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • UT Health Sciences CenterSan Antonio, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part
  • St. Louis University Medical CenterSt Louis, Egyesült ÁllamokContact: David Fernandez Vazquez, MDNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to:

A teljes eredeti leírásKevesebb

1. Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint) 2. Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint) 3. Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint)

Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form.

Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient.

A vizsgálat 2 csoportja

  • Stent

    The patient received one or more stents to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries in AT LEAST one of the lesions treated during the course of the procedure.

  • Non-Stent

    The patient did not receive a stent to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries in ANY of the lesions treated during the course of the procedure.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease
A regiszteradat frissítve
2026. február 6.