MedTrace Logo

Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System

NCT01788150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2021-05-04

Study results available
· View outcomes & findings →

Summary

A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.

The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

Conditions

Interventions

DEVICE

Coronary Stenting

Sponsors & Collaborators

  • Svelte Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Stefan Verheye, MD, PhD · Antwerp Cardiovascular Institute

  • Alexandre Abizaid, MD, PhD · Instituto Dante Pazzanese de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-05-31
Completion
2019-05-31

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Netherlands
  • Sweden
  • Switzerland

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 NCT01788150 on ClinicalTrials.gov