PEPCAD
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
Sponsor study identifier
interventional
220
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2014
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 5, 2012
Actual (reported)June 18, 2012
Actual (reported)April 2013
Actual (reported)April 2014
Actual (reported)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
Success rate of the interventional therapy
Two year
Outcomes of clinical follow-up visits for drug stent versus drug balloon
Two year
Paclitaxel Drug-eluting Coronary Artery Balloon Catheter
Paclitaxel Drug-eluting Coronary Stent and Conveying System
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
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
Fuwai CVD Hospital of Chinese Academy of Medical Sciences
Beijing, China
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.
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.
Runlin Gao, Prof.
Fuwai CVD Hospital of Chinese Academy of Medical Sciences
220 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2012
First Posted
June 18, 2012
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)
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Primary Completion
April 2013
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
July 24, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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