Drug Eluting Balloon for Treatment of Unstable Angina
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|ClinicalTrials.gov Identifier: NCT02760732|
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Angina, Unstable||Device: drug eluting balloon; cutting balloon Device: drug eluting stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||June 1, 2018|
|Estimated Study Completion Date :||August 1, 2018|
Experimental: drug eluting balloon group
patients with unstable angina were randomised to drug eluting balloon group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon(Flextome Cutting Balloon, Boston Scientific Corporation, US) pre-dilation first and then drug eluting balloon(Sequent please; B. Braun, Melsungen, Germany) .
Device: drug eluting balloon; cutting balloon
Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon.
Other Name: Sequent please; B. Braun; Flextome Cutting Balloon, Boston Scientific
Experimental: drug eluting stent group
patients with unstable angina were randomised to this group for drug eluting stent (YINYI® Polymer-free Drug-coated (Paclitaxel) Coronary Stent System, Liaoning Biomedical Materials R&D Center Co., Ltd. China) implantation.
Device: drug eluting stent
with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.
Other Name: YINYI®
- Changes in Target Lumen assessed by optical coherence tomography [ Time Frame: 12 months ]A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.
- Incidence rate of MACE [ Time Frame: Incidence rate of MACE from baseline to 12 months ]MACE include composite of death, myocardial infarction, or target-vessel revascularization
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): NCT02760732
|Contact: LI BO, MDfirstname.lastname@example.org|
|The General Hospital of PLA||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: LI BO, MD +8601055499309 22401919@QQ.COM|
|Principal Investigator:||CHEN YUN DAI, MD||The General Hospital of PLA|