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NCT03875651Completed

A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)

A U.S. Post-Approval Study of the SYNERGY 4.50/5.00 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (Evolve 4.5/5.0)

Source: ClinicalTrials.gov · Last updated 14 Dec 2023

Brief summary (registry, in English)

EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries \> 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.

Status (registry)
Completed
Study type
Observational
Enrollment
100 (actual)
First submitted
13 Mar 2019
Start date
9 May 2019
Primary completion date
7 Jan 2022
Lead sponsor
Boston Scientific Corporation
NCT number
NCT03875651

What you commit to

  • Study type: Observational
  • Participants enrolled: 100
  • From 9 May 2019 to the primary completion date, 7 Jan 2022
  • 9 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

  • Planned treatment with a non-SYNERGY stent.

Who the study is looking for

  • A patient is an acceptable candidate if they require treatment with a 4.50 or 5.00 mm SYNERGY stent for the treatment of their disease in accordance with the applicable guidelines on PCI, the SYNERGY DFU, and the Declaration of Helsinki.

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

Full criteria on ClinicalTrials.gov

Sites (9)

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

SiteCityCountrySite status
Beth Israel Deaconness Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Lindner Center for Research and Education at Christ Hospital
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Clearwater Cardiovascular Consultants
Coordinator of this site? Confirm its status
ClearwaterUnited StatesUnknown status
Baylor Heart and Vascular Hospital
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Inova Fairfax Hospital
Coordinator of this site? Confirm its status
FairfaxUnited StatesUnknown status
North Kansas City Hospital
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Yale New Haven Hospital
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Oregon Health Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Wake Medical Center
Coordinator of this site? Confirm its status
RaleighUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.