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| Name | Class |
|---|---|
| Daqing Oil Field Hospital | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| Tianjin People's Hospital | OTHER |
| Peking University First Hospital |
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The DCB-ACS trial is a prospective, multi-center, non-inferiority, randomized controlled trail. The purpose of this trial is to evaluate the safety and efficacy of drug-coated balloon(DCB) in de novo lesions for acute coronary syndromes (ACS) .
Patients with ACS and indications for percutaneous coronary intervention were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a Zotarolimus-Eluting Coronary Stent(ZES) . Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, 12 months, and 24 months after discharge, and coronary angiography and FFR measurements will be carried out at 9 months.The primary objective is to show non-inferiority of DCB versus drug-eluting stent(DES) regarding the functional assessment of target lesion by FFR at 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-coated balloon group | Experimental | Patients assigned to drug-coated balloon group will receive angioplasty with drug-coated balloon for treatment of lesions. |
|
| Stent group | Active Comparator | Patients assigned to drug-eluting stent group will receive a Zotarolimus -Eluting Coronary Stent treatment . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-coated balloon | Device | Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions and improve myocardial blood flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional flow reserve (FFR) | Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia. | 9 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure(TLF) | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and revascularization of target lesions | 1 month, 6 months, 9 months, 12 months, 24 months follow-up |
| Cardiac death |
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Inclusion Criteria:
Exclusion Criteria:
Clinical Exclusion Criteria:
1. Chronic total occlusion (CTO); 2. Left main lesion; 3. Bifurcation lesions treated with double stents; 4. Moderate to severe distortion, angulation or severe calcification lesions; 5. Coronary artery graft stenosis; 6. In-stent restenosis; 7. To be re-hospitalized for the other scheduled PCI treatment; 8. Myocardial bridge at the target lesion.
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| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, MD,PhD | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150081 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30165437 | Background | Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. | |
| 30170854 |
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| OTHER |
| Beijing Friendship Hospital | OTHER |
| Third Medical Center of Chinese PLA General Hospital | OTHER |
| Jining Medical University | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| General Hospital of Taiyuan Iron & Steel Company | UNKNOWN |
| Tongji Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Second Affiliated Hospital of Zhengzhou University | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Inner Mongolia People's Hospital | OTHER |
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| Zotarolimus-Eluting Coronary Stent | Device | Zotarolimus-Eluting Coronary Stent is treated for coronary artery stenosis lesions . |
|
| 1 month, 6 months, 9 months, 12 months, 24 months follow-up |
| Target vessel-related myocardial infarction | 12 months, 24 months follow-up |
| Revascularization of target lesion revascularization (TLR) | 1 month, 6 months, 9 months, 12 months, 24 months follow-up |
| All-cause death and myocardial infarction | 1 month, 6 months, 9 months, 12 months, 24 months follow-up |
| Major bleeding | Defined as Bleeding Academic Research Consortium type 3 to 5 | 1 month, 6 months, 9 months, 12 months, 24 months follow-up |
| Procedure success | Including device success, lesion success and procedure success | 1 month |
| Patient-oriented composite endpoint (PoCE) | A composite of all-cause mortality, myocardial infarction, and any revascularization. | 1 month, 6 months, 9 months, 12 months ,24 months follow-up |
| Diameter stenosis(DS%) | DS% defined as: (1 - minimal luminal diameter /reference vessel diameter) *100%. | 9 months follow-up |
| Late lumen loss (LLL) | The difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography. | 9 months follow-up |
| Restenosis rate of target lesion | Diameter stenosis %≥50% | 9 months |
| Definite and possible thrombotic events | 2 years |
| Rehospitalized due to angina | 2 years |
| Stroke | Diagnosed by a neurologist | 2 years |
| Background |
| Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28. |
| 25256200 | Background | Vos NS, Dirksen MT, Vink MA, van Nooijen FC, Amoroso G, Herrman JP, Kiemeneij F, Patterson MS, Slagboom T, van der Schaaf RJ. Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study. EuroIntervention. 2014 Sep;10(5):584-90. doi: 10.4244/EIJV10I5A101. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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