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

NCT01622075 | Completed Phase 3

• 1 other identifier: AE-V-S-1001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Instent Restenosis

Outcome Measures

Primary Outcomes (1)

• Late lumen loss in segment section at M9

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

  One year

Secondary Outcomes (2)

• Success rate of the interventional therapy

  Two year

• Outcomes of clinical follow-up visits for drug stent versus drug balloon

  Two year

Study Arms (2)

SeQuent® Please

EXPERIMENTAL

Paclitaxel Drug-eluting Coronary Artery Balloon Catheter

Device: SeQuent® Please

Taxus Liberte

ACTIVE COMPARATOR

Paclitaxel Drug-eluting Coronary Stent and Conveying System

Device: Taxus Liberte

Interventions

SeQuent® Please DEVICE

SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial

Also known as: Paclitaxel Drug-eluting Coronary Artery Balloon Catheter

SeQuent® Please

Taxus Liberte DEVICE

Taxus Liberte with a length of 8mm,12mm,16mm,20mm and 24mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial

Also known as: Paclitaxel Drug-eluting Coronary Stent and Conveying System

Taxus Liberte

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• B. Braun Medical International Trading Company Ltd.: lead

Study Sites (1)

Fuwai CVD Hospital of Chinese Academy of Medical Sciences

Beijing, China

Location

Related Publications (2)

• Xu B, Qian J, Ge J, Wang J, Chen F, Chen J, Wei M, Chen Y, Yang Y, Gao R; PEPCAD China ISR investigators. Two-year results and subgroup analyses of the PEPCAD China in-stent restenosis trial: A prospective, multicenter, randomized trial for the treatment of drug-eluting stent in-stent restenosis. Catheter Cardiovasc Interv. 2016 Mar;87 Suppl 1:624-9. doi: 10.1002/ccd.26401. Epub 2016 Jan 17.

  PMID: 26775079 DERIVED

• Xu B, Gao R, Wang J, Yang Y, Chen S, Liu B, Chen F, Li Z, Han Y, Fu G, Zhao Y, Ge J; PEPCAD China ISR Trial Investigators. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014 Feb;7(2):204-211. doi: 10.1016/j.jcin.2013.08.011.

  PMID: 24556098 DERIVED

Study Officials

• Runlin Gao, Prof.

  Fuwai CVD Hospital of Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 18, 2012
• Study Start: March 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

CN (1)