Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS) (DCB-ACS)

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

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) .

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; De Novo Stenosis; Clinical Trial; Acute Coronary Syndromes; ACS; DCB; Drug-Coated Balloon
• Intervention / Treatment: Device: Drug-coated balloon; Device: Zotarolimus-Eluting Coronary Stent

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.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • The Second Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug-coated balloon group; Patients assigned to drug-coated balloon group will receive angioplasty with drug-coated balloon for treatment of lesions.	Device: Drug-coated balloon; Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions and improve myocardial blood flow.
Active Comparator: Stent group; Patients assigned to drug-eluting stent group will receive a Zotarolimus -Eluting Coronary Stent treatment .	Device: Zotarolimus-Eluting Coronary Stent; Zotarolimus-Eluting Coronary Stent is treated for coronary artery stenosis lesions .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Peking University First Hospital; Beijing Friendship Hospital; Tongji Hospital; The First Hospital of Jilin University; Second Affiliated Hospital of Zhengzhou University; Sir Run Run Shaw Hospital; Sichuan Provincial People's Hospital; Inner Mongolia People's Hospital; Jining Medical University; Tianjin People's Hospital; Daqing Oil Field Hospital; Third Affiliated Hospital of Chinese Pla General Hospital; General Hospital of Taiyuan Iron & Steel Company; Fuwai Central China Cardiovascular Hospital
• Investigators: Principal Investigator: Bo Yu, MD,PhD, The Second Affiliated Hospital of Harbin Medical University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): February 18, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Drug-Coated Balloon; Clinical Trial; ACS; DCB; Acute Coronary Syndromes; De-novo Lesions; DCB-ACS
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: LPCTP-2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No