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A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)

NCT03350542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-05-14

Study results available
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Summary

EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) \> 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).

Conditions

Interventions

DEVICE

SYNERGY 48 mm

A drug eluting coronary stent system

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Dimitrios Karmpaliotis, MD · New York Presbyterian Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2020-01-16
Completion
2021-01-08
FDA Device
Yes

Countries

  • United States
  • Latvia
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350542 on ClinicalTrials.gov