NCT04937803

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) .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

June 10, 2021

Last Update Submit

July 15, 2024

Conditions

Drug-Coated BalloonDe Novo StenosisAcute Coronary SyndromesACSDCBClinical TrialCoronary Artery Disease

Keywords

Drug-Coated BalloonDe-novo LesionsAcute Coronary SyndromesDCB-ACSACSDCBClinical TrialCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Target lesion failure（TLF）

    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

  • +9 more secondary outcomes

Study Arms (2)

Drug-coated balloon group

EXPERIMENTAL

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

Device: Drug-coated balloon

Stent group

ACTIVE COMPARATOR

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

Device: Zotarolimus-Eluting Coronary Stent

Interventions

Drug-coated balloonDEVICE

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

Drug-coated balloon group
Zotarolimus-Eluting Coronary StentDEVICE

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

Stent group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Related Publications (3)

  • 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.

    PMID: 30165437BACKGROUND

  • 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.

    PMID: 30170854BACKGROUND

  • 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.

    PMID: 25256200BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Bo Yu, MD,PhD

    The Second Affiliated Hospital of Harbin Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Head of cardiology department

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 24, 2021

Study Start

April 19, 2021

Primary Completion

February 18, 2023

Study Completion

November 17, 2023

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)