Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01622075
NCT01622075
Completed
Phase 3

A Multicenter, Randomized, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of the Treatment of In-stent Restenosis Lesion by Paclitaxel-eluting PTCA- Balloon Catheter Versus Paclitaxel-eluting Stent

B. Braun Medical International Trading Company Ltd.1 site in 1 country220 target enrollmentMarch 2011
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCoronary Instent Restenosis

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Coronary Instent Restenosis
Sponsor
B. Braun Medical International Trading Company Ltd.
Enrollment
220
Locations
1
Primary Endpoint
Late lumen loss in segment section at M9
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of successful interventional therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface area) versus paclitaxel-eluting stent Taxus® Liberte, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤30mm.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
April 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
B. Braun Medical International Trading Company Ltd.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Related to patients
  • •Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia
  • •Restenosis after the first stent implant
  • •Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
  • •Patient aged 18-80 (including 18 and 80)
  • •Female patients of childbearing age in the study period shall not be pregnant or protocol to be pregnant, it is suggested that patients shall take sufficient contraception measures till (including) the follow-up visit of month 9
  • •Patients who agree to accept the angiography follow-up visits of month 9
  • •Patients who agree to accept the clinical visits at Day 30, Month 6 and Month 12
  • •Patients can understand the study objectives psychologically and linguistically and show the sufficient compliance to the study protocol. Patients present acceptance of the risks and benefits described in the informed consent form.
  • •Related to lesion

Exclusion Criteria

  • •Related to patients
  • •Patients with myocardial infarction within one week
  • •Patients with severe congestive heart failure or NYHA IV severe heart failure
  • •Patients with severe valvular heart disease
  • •Female patients in pregnancy or lactation
  • •Patients with the life expectancy not exceeding 1 year or the factors causing difficult clinical follow-up visits
  • •Patients with hemorrhagic tendency, prohibited to take anticoagulants or antiplatelet drugs
  • •Patients with stroke within 6 months before the surgery
  • •Patients taking part in any other clinical tests
  • •Existing sever renal failure (GFR\<30ml/min) or the history, so not meeting the conditions of angiography

Outcomes

Primary Outcomes

Late lumen loss in segment section at M9

Time Frame: One year

To measure the diameter loss in segment restenosis of the target lesion vessel by using angiography

Secondary Outcomes

  • Outcomes of clinical follow-up visits for drug stent versus drug balloon(Two year)
  • Success rate of the interventional therapy(Two year)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)Iron Deficiency Anemia
NCT00982007American Regent, Inc.997
Not Yet Recruiting
N/A
Clinical Study on the Noninvasive Lung Fluid Monitoring System in Guiding the Treatment of Heart FailureHeart Failure
NCT06102031Shanghai Zhongshan Hospital1,000
Terminated
Phase 3
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)HIV Infection
NCT00443703Merck Sharp & Dohme LLC352
Terminated
Phase 3
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)HIV Infection
NCT00443729Merck Sharp & Dohme LLC355
Terminated
Phase 4
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice ForielleInfertility
NCT03387059Merck KGaA, Darmstadt, Germany9