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

Primary Purpose

Drug-Coated Balloon, De Novo Stenosis, Acute Coronary Syndromes

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Drug-coated balloon

Zotarolimus-Eluting Coronary Stent

About this trial

This is an interventional treatment trial for Drug-Coated Balloon focused on measuring Drug-Coated Balloon, De-novo Lesions, Acute Coronary Syndromes, DCB-ACS, ACS, DCB, Clinical Trial, Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age≥18 Years and <80 years;
ACS patients eligible for percutaneous coronary intervention;
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;
Vessel diameter from 2.25mm-4.0 mm ;
Lesion length ≤ 28 mm;
A single culprit lesion or 1 lesion in each of two vessels ;
Eligible for enrollment and provide written informed consent.

Exclusion Criteria:

Clinical Exclusion Criteria：

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

Sites / Locations

The Second Affiliated Hospital of Harbin Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug-coated balloon group

Stent group

Arm Description

Patients assigned to drug-coated balloon group will receive angioplasty with drug-coated balloon for treatment of lesions.

Patients assigned to drug-eluting stent group will receive a Zotarolimus -Eluting Coronary Stent treatment .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Target lesion failure（TLF）

A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and revascularization of target lesions

Cardiac death

Target vessel-related myocardial infarction

Revascularization of target lesion revascularization (TLR)

All-cause death and myocardial infarction

Major bleeding

Defined as Bleeding Academic Research Consortium type 3 to 5

Procedure success

Including device success, lesion success and procedure success

Patient-oriented composite endpoint (PoCE)

A composite of all-cause mortality, myocardial infarction, and any revascularization.

Diameter stenosis(DS%)

DS% defined as: (1 - minimal luminal diameter /reference vessel diameter) *100%.

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.

Restenosis rate of target lesion

Diameter stenosis %≥50%

Definite and possible thrombotic events

Rehospitalized due to angina

Stroke

Diagnosed by a neurologist

Full Information

NCT ID

NCT04937803

First Posted

June 10, 2021

Last Updated

August 21, 2023

Sponsor

Harbin Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04937803

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 19, 2021 (Actual)

Primary Completion Date

February 18, 2023 (Actual)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harbin Medical University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug-coated balloon group

Arm Type

Experimental

Arm Description

Patients assigned to drug-coated balloon group will receive angioplasty with drug-coated balloon for treatment of lesions.

Arm Title

Stent group

Arm Type

Active Comparator

Arm Description

Patients assigned to drug-eluting stent group will receive a Zotarolimus -Eluting Coronary Stent treatment .

Intervention Type

Device

Intervention Name(s)

Drug-coated balloon

Intervention Description

Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions and improve myocardial blood flow.

Intervention Type

Device

Intervention Name(s)

Zotarolimus-Eluting Coronary Stent

Intervention Description

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

Primary Outcome Measure Information:

Title

Fractional flow reserve (FFR)

Description

Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.

Time Frame

9 months follow-up

Secondary Outcome Measure Information:

Title

Target lesion failure（TLF）

Description

A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and revascularization of target lesions

Time Frame

1 month, 6 months, 9 months, 12 months, 24 months follow-up

Title

Cardiac death

Time Frame

1 month, 6 months, 9 months, 12 months, 24 months follow-up

Title

Target vessel-related myocardial infarction

Time Frame

12 months, 24 months follow-up

Title

Revascularization of target lesion revascularization (TLR)

Time Frame

1 month, 6 months, 9 months, 12 months, 24 months follow-up

Title

All-cause death and myocardial infarction

Time Frame

1 month, 6 months, 9 months, 12 months, 24 months follow-up

Title

Major bleeding

Description

Defined as Bleeding Academic Research Consortium type 3 to 5

Time Frame

1 month, 6 months, 9 months, 12 months, 24 months follow-up

Title

Procedure success

Description

Including device success, lesion success and procedure success

Time Frame

1 month

Title

Patient-oriented composite endpoint (PoCE)

Description

A composite of all-cause mortality, myocardial infarction, and any revascularization.

Time Frame

1 month, 6 months, 9 months, 12 months ,24 months follow-up

Title

Diameter stenosis(DS%)

Description

DS% defined as: (1 - minimal luminal diameter /reference vessel diameter) *100%.

Time Frame

9 months follow-up

Title

Late lumen loss (LLL）

Description

The difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography.

Time Frame

9 months follow-up

Title

Restenosis rate of target lesion

Description

Diameter stenosis %≥50%

Time Frame

9 months

Title

Definite and possible thrombotic events

Time Frame

2 years

Title

Rehospitalized due to angina

Time Frame

2 years

Title

Stroke

Description

Diagnosed by a neurologist

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age≥18 Years and <80 years; ACS patients eligible for percutaneous coronary intervention; 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; Vessel diameter from 2.25mm-4.0 mm ; Lesion length ≤ 28 mm; A single culprit lesion or 1 lesion in each of two vessels ; Eligible for enrollment and provide written informed consent. Exclusion Criteria: Clinical Exclusion Criteria： Stable angina or asymptomatic myocardial ischemia; Cardiogenic shock or requiring mechanical support for breathing and circulation; Hemodynamically unstable tachyarrhythmia or bradyarrhythmia; Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention; A history of stroke within 6 months; History of severe renal insufficiency; Life expectancy < 12 months; Pregnant women; Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases; Patients not suitable for enrollment considered by researcher; Currently participating in another trial before reaching the primary endpoint; 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Yu, MD,PhD

Organizational Affiliation

The Second Affiliated Hospital of Harbin Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second Affiliated Hospital of Harbin Medical University

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150081

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30165437

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.

Results Reference

background

PubMed Identifier

30170854

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.

Results Reference

background

PubMed Identifier

25256200

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.

Results Reference

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Learn more about this trial

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

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