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SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent

NCT00917163 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-08-23

No results posted yet for this study

Summary

The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.

Conditions

Interventions

DEVICE

Supralimus(R) Sirolimus-Eluting Coronary Stent System

Drug eluting stent implantation in the treatment of coronary artery disease.

DEVICE

Xience V™ Everolimus Eluting Coronary Stent

Drug eluting stent implantation in the treatment of coronary artery disease

Sponsors & Collaborators

  • Cardialysis BV

    collaborator INDUSTRY

  • Sahajanand Medical Technologies Limited

    lead INDUSTRY

Principal Investigators

  • Prof. Patrick W Serruys, MD, Ph.D · Thoraxcenter,Rotterdam,NL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Brazil
  • India
  • Saudi Arabia

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 NCT00917163 on ClinicalTrials.gov