Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries
|ClinicalTrials.gov Identifier: NCT01903902|
Recruitment Status : Unknown
Verified July 2013 by Woong Chol Kang, Gachon University Gil Medical Center.
Recruitment status was: Recruiting
First Posted : July 19, 2013
Last Update Posted : July 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: SeQuent® Please Drug-eluting balloon||Phase 4|
Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis.
DEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied.
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
Experimental: Drug-eluting balloon
Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter > 2.25 mm and ≤ 2.75 mm)
Device: SeQuent® Please Drug-eluting balloon
Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length < 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.
- Late loss [ Time Frame: 9±1 months ]Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary
- Binary restenosis rate [ Time Frame: 9±1 months ]Restenosis rate of the target lesion at the follow-up quantitative coronary angiography
- Neointimal hyperplasia [ Time Frame: 9±1 months ]Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam
- Clinical outcomes [ Time Frame: 9±1 months ]Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903902
|Contact: Woong Chul Kang, M.D.||+firstname.lastname@example.org|
|Korea, Republic of|
|Gachon University Gil Medical Center||Recruiting|
|Incheon, Korea, Republic of, 405-760|
|Contact: Woong Chul Kang, M.D. +82-32-460-3663 email@example.com|
|Principal Investigator: Woong Chul Kang, M.D.|
|Principal Investigator:||Woong Chul Kang, M.D.||Gachon University Gil Medical Center|