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INDICOR The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent

NCT00747357 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2016-02-19

No results posted yet for this study

Summary

The INDICOR study is a controlled, prospective, multicenter, randomized, two arm phase-II real world study assessing the acute, 6 months, and 12 months and 3 year outcome of cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) followed by cobalt-chromium stent (Coroflex Blue) deployment for the treatment of de-novo and restenotic lesions in native coronary arteries. The study will be conducted in India.

Conditions

  • Coronary Heart Diseases

Interventions

DEVICE

Drug Eluting Balloon SeQuent Please

Drug Eluting Balloon is followed by Bare Metal Stent

DEVICE

Drug Eluting Balloon SeQuent Please

Bare Metal Stent followed by Drug Eluting Balloon

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Ralf Degenhardt, PhD

    lead OTHER

Principal Investigators

  • Upendra kAUL, Dr. · Fortis Flt.Lt.Rajan Dhall Hospital, New Delhi, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-09-30
Completion
2016-01-31

Countries

  • India

Study Locations

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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 NCT00747357 on ClinicalTrials.gov