Clinical trial NCT04937803: Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)
Official title: Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS): A Prospective, Multi-Center, Randomized-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug-Coated Balloon
De Novo Stenosis
Acute Coronary Syndromes
ACS
DCB
Clinical Trial
Coronary Artery Disease
Keywords: Drug-Coated Balloon
De-novo Lesions
Acute Coronary Syndromes
DCB-ACS
ACS
DCB
Clinical Trial
Coronary Artery Disease
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Daqing Oil Field Hospital
name: Sichuan Provincial People's Hospital
name: Tianjin People's Hospital
name: Peking University First Hospital
name: Beijing Friendship Hospital
name: The Third Medical Center, Chinese PLA General Hospital
name: Jining Medical University
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: The First Hospital of Jilin University
name: General Hospital of Taiyuan Iron & Steel Company
name: Tongji Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital of Zhengzhou University
name: Sir Run Run Shaw Hospital
name: Inner Mongolia People's Hospital
First posted: 2021-06-24
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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) .

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age≥18 Years and \<80 years;
2. ACS patients eligible for percutaneous coronary intervention;
3. Successful preparation is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of type C-F dissection;
4. Vessel diameter from 2.25mm-4.0 mm ;
5. Lesion length ≤ 28 mm;
6. A single culprit lesion or 1 lesion in each of two vessels ;
7. Eligible for enrollment and provide written informed consent.

Exclusion Criteria:

Clinical Exclusion Criteria：

1. Stable angina or asymptomatic myocardial ischemia;
2. Cardiogenic shock or requiring mechanical support for breathing and circulation;
3. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
4. Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention;
5. A history of stroke within 6 months;
6. History of severe renal insufficiency;
7. Life expectancy \< 12 months;
8. Pregnant women;
9. Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases;
10. Patients not suitable for enrollment considered by researcher;
11. Currently participating in another trial before reaching the primary endpoint;
12. Inability to provide informed consent. Image 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.

Primary outcomes:
measure: Fractional flow reserve (FFR)
timeFrame: 9 months follow-up
Secondary outcomes:
measure: Target lesion failure（TLF）
timeFrame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
measure: Cardiac death
timeFrame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
measure: Target vessel-related myocardial infarction
timeFrame: 12 months, 24 months follow-up
measure: Revascularization of target lesion revascularization (TLR)
timeFrame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
measure: All-cause death and myocardial infarction
timeFrame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
measure: Major bleeding
timeFrame: 1 month, 6 months, 9 months, 12 months, 24 months follow-up
measure: Procedure success
timeFrame: 1 month
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 1 month, 6 months, 9 months, 12 months ,24 months follow-up
measure: Diameter stenosis(DS%)
timeFrame: 9 months follow-up
measure: Late lumen loss (LLL）
timeFrame: 9 months follow-up
measure: Restenosis rate of target lesion
timeFrame: 9 months
measure: Definite and possible thrombotic events
timeFrame: 2 years
measure: Rehospitalized due to angina
timeFrame: 2 years
measure: Stroke
timeFrame: 2 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.