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Paclitaxel Eluting Balloon Versus Drug Eluting Stent in Native Coronary Artery Stenoses of Diabetic Patients

NCT00462631 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2016-02-19

No results posted yet for this study

Summary

The aim of the study is to compare the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment versus Paclitaxel-eluting stent (TaxusTM LibertéTM) deployment in the treatment of de-novo-stenoses in native coronary arteries (reference diameter:more then 2.5 mm and below 3.5 mm, length of stenosis ≥ 10 mm ≤ 20 mm) of patients with diabetes mellitus for ≥ 3 years for procedural success and preservation of vessel patency.

This study is a prospective, randomized, multi-center, two-armed phase-II pilot study conducted in Malaysia and Thailand.

128 diabetes mellitus patients shall complete the study per protocol after random assignment to either of the treatment groups on the order of 20 to 50 patients per center.

Diabetes mellitus patients with stable or selected forms of unstable angina or documented ischemia due to a de-novo stenosis in a native coronary artery will be enrolled. Vessels may not supply an entirely infarcted myocardial area.

Late lumen loss at 9 months is the primary endpoint.

Conditions

Interventions

DEVICE

Paclitaxel Eluting Balloon

Paclitaxel eluting balloon

DEVICE

paclitaxel eluting stent

paclitaxel eluting stent

DEVICE

bare metal stent

bare metal stent

Sponsors & Collaborators

  • B. Braun Medical SA

    collaborator INDUSTRY

  • Heart Centre Rotenburg

    lead OTHER

Principal Investigators

  • Rosli M Ali, MD · Cardiology Department Institut Jantung Negara National Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-09-30
Completion
2016-02-29

Countries

  • Malaysia

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 NCT00462631 on ClinicalTrials.gov