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

Sponsor
Harbin Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04937803
Collaborator
Daqing Oil Field Hospital (Other), Sichuan Provincial People's Hospital (Other), Tianjin People's Hospital (Other), Peking University First Hospital (Other), Beijing Friendship Hospital (Other), Third Affiliated Hospital of Chinese Pla General Hospital (Other), Jining Medical University (Other), Fuwai Central China Cardiovascular Hospital (Other), The First Hospital of Jilin University (Other), General Hospital of Taiyuan Iron & Steel Company (Other), 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)
216
1
2
35.4
6.1

Study Details

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) .

Condition or Disease Intervention/Treatment Phase
  • Device: Drug-coated balloon
  • Device: Zotarolimus-Eluting Coronary Stent
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 19, 2021
Anticipated Primary Completion Date :
Sep 18, 2022
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

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 .

Outcome Measures

Primary Outcome Measures

  1. Fractional flow reserve (FFR) [9 months follow-up]

    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

  1. Target lesion failure(TLF) [1 month, 6 months, 9 months, 12 months, 24 months follow-up]

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

  2. Cardiac death [1 month, 6 months, 9 months, 12 months, 24 months follow-up]

  3. Target vessel-related myocardial infarction [12 months, 24 months follow-up]

  4. Revascularization of target lesion revascularization (TLR) [1 month, 6 months, 9 months, 12 months, 24 months follow-up]

  5. All-cause death and myocardial infarction [1 month, 6 months, 9 months, 12 months, 24 months follow-up]

  6. Major bleeding [1 month, 6 months, 9 months, 12 months, 24 months follow-up]

    Defined as Bleeding Academic Research Consortium type 3 to 5

  7. Procedure success [1 month]

    Including device success, lesion success and procedure success

  8. Patient-oriented composite endpoint (PoCE) [1 month, 6 months, 9 months, 12 months ,24 months follow-up]

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

  9. Diameter stenosis(DS%) [9 months follow-up]

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

  10. Late lumen loss (LLL) [9 months follow-up]

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

  11. Restenosis rate of target lesion [9 months]

    Diameter stenosis %≥50%

  12. Definite and possible thrombotic events [2 years]

  13. Rehospitalized due to angina [2 years]

  14. Stroke [2 years]

    Diagnosed by a neurologist

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  13. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150081

Sponsors and Collaborators

  • Harbin Medical University
  • 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

Investigators

  • Principal Investigator: Bo Yu, MD,PhD, The Second Affiliated Hospital of Harbin Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yu Bo, The Head of cardiology department, The Second Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier:
NCT04937803
Other Study ID Numbers:
  • LPCTP-2020-001
First Posted:
Jun 24, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu Bo, The Head of cardiology department, The Second Affiliated Hospital of Harbin Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021