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Drug-Coated BalloonDCB-ACSNCT04937803

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

A study testing Drug-coated balloon and Zotarolimus-Eluting Coronary Stent in people with Drug-Coated Balloon and De Novo Stenosis, run by Harbin Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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) . Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Drug-coated balloon and Zotarolimus-Eluting Coronary Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
19 Apr 2021to 17 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

Other trials in China

About this study

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

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) .

Read the 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.

Being tested
Drug-coated balloon, Zotarolimus-Eluting Coronary Stent
Keywords
Drug-Coated Balloon, De-novo Lesions, Acute Coronary Syndromes, DCB-ACS, ACS, DCB, Clinical Trial, Coronary Artery Disease
Medical subject headings
Acute Coronary Syndrome, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Zotarolimus-Eluting Coronary StentDevice

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

Study groups in NCT04937803
Study groupRoleWhat they receive
Drug-coated balloon groupExperimentalPatients assigned to drug-coated balloon group will receive angioplasty with drug-coated balloon for treatment of lesions.
Receives: Device: Drug-coated balloon
Stent groupActive comparatorPatients assigned to drug-eluting stent group will receive a Zotarolimus -Eluting Coronary Stent treatment .
Receives: Device: Zotarolimus-Eluting Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months follow-up

Secondary outcomes (14)

  1. Target lesion failure（TLF）

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

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

  2. Cardiac death

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

  3. Target vessel-related myocardial infarction

    Measured: 12 months, 24 months follow-up

  4. Revascularization of target lesion revascularization (TLR)

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

  5. All-cause death and myocardial infarction

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

  6. Major bleeding

    Defined as Bleeding Academic Research Consortium type 3 to 5

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

  7. Procedure success

    Including device success, lesion success and procedure success

    Measured: 1 month

  8. Patient-oriented composite endpoint (PoCE)

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

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

  9. Diameter stenosis(DS%)

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

    Measured: 9 months follow-up

  10. 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.

    Measured: 9 months follow-up

  11. Restenosis rate of target lesion

    Diameter stenosis %≥50%

    Measured: 9 months

  12. Definite and possible thrombotic events

    Measured: 2 years

  13. Rehospitalized due to angina

    Measured: 2 years

  14. Stroke

    Diagnosed by a neurologist

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2021
  2. Study start19 Apr 2021
  3. Primary completion18 Feb 2023
  4. Study completion17 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04937803
Sponsor's protocol ID
LPCTP-2020-001
Acronym
DCB-ACS
Status last verified
Jul 2024
First submitted
10 Jun 2021
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30165437

  • 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.

    PubMed 30170854

  • 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.

    PubMed 25256200

Questions about this trial

What is this clinical trial studying?

A study testing Drug-coated balloon and Zotarolimus-Eluting Coronary Stent in people with Drug-Coated Balloon and De Novo Stenosis, run by Harbin Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fractional flow reserve (FFR) (time frame: 9 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04937803, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.

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