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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04937803
• Other study ID #: LPCTP-2020-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2023
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: March 31, 2024
• Est. primary completion date: February 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACS
• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Clinical Trial
• Coronary Artery Disease
• Coronary Disease
• DCB
• De Novo Stenosis
• Drug-Coated Balloon
• Myocardial Ischemia
• Syndrome

Intervention

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.
• Zotarolimus-Eluting Coronary Stent
Zotarolimus-Eluting Coronary Stent is treated for coronary artery stenosis lesions .

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (16)

Lead Sponsor

Collaborator

Harbin Medical University

Beijing Friendship Hospital, Daqing Oil Field Hospital, Fuwai Central China Cardiovascular Hospital, General Hospital of Taiyuan Iron & Steel Company, Inner Mongolia People's Hospital, Jining Medical University, Peking University First Hospital, Second Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Hospital of Jilin University, Third Affiliated Hospital of Chinese Pla General Hospital, Tianjin People's Hospital, Tongji Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cardiac death		1 month, 6 months, 9 months, 12 months, 24 months follow-up
Secondary	Target vessel-related myocardial infarction		12 months, 24 months follow-up
Secondary	Revascularization of target lesion revascularization (TLR)		1 month, 6 months, 9 months, 12 months, 24 months follow-up
Secondary	All-cause death and myocardial infarction		1 month, 6 months, 9 months, 12 months, 24 months follow-up
Secondary	Major bleeding	Defined as Bleeding Academic Research Consortium type 3 to 5	1 month, 6 months, 9 months, 12 months, 24 months follow-up
Secondary	Procedure success	Including device success, lesion success and procedure success	1 month
Secondary	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
Secondary	Diameter stenosis(DS%)	DS% defined as: (1 - minimal luminal diameter /reference vessel diameter) *100%.	9 months follow-up
Secondary	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
Secondary	Restenosis rate of target lesion	Diameter stenosis %=50%	9 months
Secondary	Definite and possible thrombotic events		2 years
Secondary	Rehospitalized due to angina		2 years
Secondary	Stroke	Diagnosed by a neurologist	2 years