A Safety and Efficacy Study of Paclitaxel-eluting Balloon to Paclitaxel-eluting Stent

Phase 3

Completed

• Conditions: Coronary Instent Restenosis
• Interventions: Device: Taxus Liberte; Device: SeQuent® Please

• Registration Number: NCT01622075
• Lead Sponsor: B. Braun Medical International Trading Company Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Primary Completion: 2013-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. 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.

2. Related to lesion

   • Drug-eluting stent restenosis: Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length ≤30mm
   • Before surgery, stenosis diameter must be ≥70% or ≥50% and accompanied by ischemia
   • The distance between other lesion requires interventional therapy and the target lesion must be >10mm
   • In the stent group, up to two paclitaxel drug stents are permitted to be implanted in series

Exclusion Criteria

1. 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
   • Patients with cardiac transplantation
   • Patients not included for other reasons from the investigators

2. Related to lesion

   • Evidence of extensive thrombus in target blood vessel before the intervention
   • Percutaneous coronary intervention for many in-stent restenosis lesions in same artery
   • 3-vessel disease that all need to be intervented
   • In bifurcation lesions, branch open blood vessel diameter ≥2.5mm
   • Percutaneous coronary intervention of venous graft
   • Entire shut of Grade TIMI 0 blood flow (Type Mehran IV stenosis)
   • Open lesion at left primary and within 2mm

3. Related to concomitant therapy

   • Patients cannot tolerate aspirin and/or clopidogrel, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel
   • Patients known allergic to paclitaxel
   • Patients with the history of leucopenia (numeration of leukocytes <3x109/L, exceeding 3 days), neutrocytopenia (ANC<1000 neutrocytes/mm3, exceeding 3 days) or thrombocytopenia (<100,000 platelets/mm3
   • Patients with the history of peptic ulcer or gastrointestinal hemorrhage in the past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taxus Liberte	Taxus Liberte	Paclitaxel Drug-eluting Coronary Stent and Conveying System
SeQuent® Please	SeQuent® Please	Paclitaxel Drug-eluting Coronary Artery Balloon Catheter

Primary Outcome Measures

Name	Time	Method
Late lumen loss in segment section at M9	One year	To measure the diameter loss in segment restenosis of the target lesion vessel by using angiography

Secondary Outcome Measures

Name	Time	Method
Outcomes of clinical follow-up visits for drug stent versus drug balloon	Two year	* Binary restenosis rate in lesion section at M9; * Cardiovascular clinical composite endpoints related to apparatus at D30, M6, M9, M12 and M24, including cardiac death, target blood vessel myocardial infarction and target lesion vessel revascularization driven by clinical symptoms, briefed as target lesion failure; * Cardiovascular clinical composite endpoints related to patients at D30, M6, M9, M12 and M24, including all-cause death, all myocardial infarction and any vessel revascularization; * Thrombus event rate defined by ARC
Success rate of the interventional therapy	Two year	To compare the successful treatment of coronary artery stent restenosis intervention between Paclitaxel release PTCA balloon and Taxus® Liberte, including apparatus success, lesion success and clinical success

Trial Locations

Locations (1)

Fuwai CVD Hospital of Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China