CompletedNot Applicable

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

China216 participantsStarted 2021-04-19

Plain-language 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) .

Who can participate

Age range18 Years – 80 Years

SexALL

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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

✕. 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;

What they're measuring

Fractional flow reserve (FFR)

Timeframe: 9 months follow-up

Trial details

NCT IDNCT04937803

SponsorHarbin Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-18

View on ClinicalTrials.gov More Drug-Coated Balloon trials