Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|