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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SeQuent® Please | Experimental | Paclitaxel Drug-eluting Coronary Artery Balloon Catheter |
|
| Taxus Liberte | Active Comparator | Paclitaxel Drug-eluting Coronary Stent and Conveying System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of the interventional therapy | 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 | Two year |
| Outcomes of clinical follow-up visits for drug stent versus drug balloon |
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Inclusion Criteria:
Related to patients
Related to lesion
Exclusion Criteria:
Related to patients
Related to lesion
Related to concomitant therapy
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| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao, Prof. | Fuwai CVD Hospital of Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai CVD Hospital of Chinese Academy of Medical Sciences | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26775079 | Derived | 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. | |
| 24556098 |
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|
| 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 |
|
|
|
| Two year |
| 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. |