CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 159 enrolled
Drug / intervention
Coronary Stentingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01788150
NCT01788150N/ACompleted

Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)

Svelte Medical Systems, Inc.·interventional·Posted Feb 11, 2013·Updated May 4, 2021

In Brief

A clinical study evaluating Coronary Stenting for Coronary Artery Disease. Completed, enrolled 159 participants across 18 sites in 7 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Czechia, France, Germany, Netherlands, Sweden, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2013
Enrollment StartJan 1, 2013
Primary CompletionMay 1, 2014
Study CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.4 years ago

Interventions

Coronary Stentingdevice