AzTrials
AzTrials

Coronary Artery DiseaseREVERSENCT05846893

Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

A study testing SeQuent® Please NEO drug-coated balloon catheter and Current-generation drug-eluting stent in people with Coronary Artery Disease and Myocardial Ischemia, run by B. Braun Medical Industries Sdn. Bhd. at 21 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SeQuent® Please NEO drug-coated balloon catheter and Current-generation drug-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,436 participants
Where
21 sitesin 4 countries
Study dates
7 Sep 2023to Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient-related:
  • Patient must be ≥ 18 years of age
  • Patient is able to verbally confirm understanding of the study aim, risks, benefits, and treatment alternatives of receiving DCB or DES and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure
  • (i) Clinical evidence of angina, and/or (ii) an abnormal functional study demonstrating myocardial ischemia due to the target lesion(s), or (iii) acute coronary syndrome [unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)]
  • Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use
  • Patient is able to comply with the study protocol and agrees to undergo the clinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months
Show all 11Show fewer
  • Lesion-related:
  • Presence of significant de novo large vessel coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation) with either ≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with abnormal functional test or symptom of ischemia
  • Successful lesion preparation. For randomisation, the lesion must satisfy the following criteria after optimal balloon angioplasty: no flow-limiting dissection (TIMI=3), and residual stenosis is ≤ 30%
  • Multivessel disease with two or more vessels showing diameter stenosis of 50% or more is not an exclusion as long as it fulfills all study's eligibility criteria.
  • In diffuse lesion, inclusion is possible if the proximal reference vessel diameter is 3.0 mm or more.

Who cannot join

  • Patient-related:
  • Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide)
  • Severe allergy to contrast media
  • Recent STEMI (ongoing or < 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)
  • NSTEMI hemodynamically unstable
  • Known left ventricular ejection fraction of <30%
Show all 22Show fewer
  • Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months
  • Non-cardiac co-morbid conditions that may result in protocol non-compliance and inability of patient to complete the study (per the site investigator's medical judgment)
  • Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy
  • Patient who is currently/ planning to participate in another clinical trial when such participation could confound the treatment or outcomes of this study, except for observational registry
  • Pregnancy or lactation
  • Patient under administrative or judicial custody
  • Lesion-related:
  • Small vessel disease, defined as <3.0 mm of reference vessel diameter by visual estimation
  • In-stent restenosis lesions for study lesions
  • Patient will be excluded if meet any of the following angiographic exclusion criteria after lesion preparation:
  • Flow limiting dissection with TIMI flow < III (ii) Residual diameter stenosis >30%
  • The case of persistent ischemic symptoms/signs is up to the operator's decision
  • Lesions which are untreatable with PCI or other interventional techniques and coronary artery spasm in the absence of a significant stenosis
  • Left main disease or aorta-ostial lesion requiring revascularization
  • Severely calcified or tortuous vessels precluding DCB or DES application
  • Prior Coronary Artery Bypass Graft (CABG)

Trial locations and contacts

21 sites in 4 countries.

21 sites in 4 countries

South Korea9 sites

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355

  • Gyeongsang National University Changwon Hospital

    Changwon, Gyeongsangnam-do, 51472

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 24289

  • Keimyung University Dongsan Hospital

    Daegu, Daegu, 42601

  • Chonnam National University Hospital

    Donggu, Gwangju, 61469

  • Ulsan University Hospital

    Donggu, Ulsan, 44033

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do, 10380

  • Kangbuk Samsung Hospital

    Seoul, Seoul, 13631

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Malaysia6 sites

  • Sultan Idris Shah Serdang Hospital

    Kajang, Selangor, 43000

  • Queen Elizabeth II Hospital

    Kota Kinabalu, Sabah, 88300

  • National Heart Institute Malaysia

    Kuala Lumpur, Kuala Lumpur, 50400

  • Cardiac Vascular Sentral Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50470

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • Sarawak Heart Center

    Kuching, Sarawak, 94300

Other trials in Malaysia

Singapore3 sites

  • Tan Tock Seng Hospital

    Novena, 308433

  • National Heart Centre Singapore

    Singapore, 169609

  • Khoo Teck Puat Hospital

    Singapore, 768828

Other trials in Singapore

Taiwan3 sites

  • Far Eastern Memorial Hospital

    New Taipei City, 220216

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

About this study

Official title: Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.

Read the detailed description

Although several reports suggested that DCB application was safe for larger coronary artery lesions and showed good long-term outcomes, there is limited randomised controlled trial (RCT) data on the safety and efficacy of DCB in large coronary artery disease.

Therefore, the study aims to demonstrate the non-inferiority of the drug-coated balloon (DCB) treatment against current-generation drug-eluting stenting (DES) in patients with de novo lesions in large coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation).

The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES.

Being tested
SeQuent® Please NEO drug-coated balloon catheter, Current-generation drug-eluting stent
Keywords
de novo, large vessel, coronary artery disease, cardiovascular disease, coronary occlusion, heart disease, acute coronary syndrome, angina, ischemia, stenosis, percutaneous coronary intervention, angioplasty, drug-coated balloon, drug-eluting stent, SeQuent Please, randomised trial
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Coronary Stenosis, Cardiovascular Diseases, Coronary Occlusion, Heart Diseases, Angina Pectoris

What participants receive

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

  • SeQuent® Please NEO drug-coated balloon catheterDevice

    Treatment of coronary artery disease with SeQuent® Please NEO for de novo lesions in native large coronary arteries

  • Current-generation drug-eluting stentDevice

    Treatment of coronary artery disease with current-generation drug-eluting stent for de novo lesions in native large coronary arteries

Study groups in NCT05846893
Study groupRoleWhat they receive
SeQuent® Please NEO drug-coated balloon catheterExperimentalNot described
Receives: Device: SeQuent® Please NEO drug-coated balloon catheter
Current-generation drug-eluting stentExperimentalNot described
Receives: Device: Current-generation drug-eluting stent

What is being measured

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

  1. Net Adverse Clinical Event (NACE)

    Net adverse clinical event (NACE): a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or major bleeding (BARC type 3 to 5)

    Measured: At 1 year

Secondary outcomes (15)

  1. All-cause death

    Measured: At 12, 24, and 36 months

  2. Non-fatal myocardial infarction

    Measured: At 12, 24, and 36 months

  3. Clinically driven target vessel revascularization

    Measured: At 12, 24, and 36 months

  4. Major bleeding (BARC type 3 to 5)

    Measured: At 12, 24, and 36 months

  5. Cardiac death

    Measured: At 12, 24, and 36 months

  6. Target vessel myocardial infarction

    Measured: At 12, 24, and 36 months

  7. Periprocedural myocardial infarction

    Measured: At 12, 24, and 36 months

  8. Target lesion revascularization

    Measured: At 12, 24, and 36 months

  9. Stent/lesion thrombosis in treated lesion defined according to the Academic Research Consortium-2 (ARC-2) criteria

    Measured: At 12, 24, and 36 months

  10. Rehospitalization related to study endpoints

    Rate of hospitalization related to study endpoints

    Measured: At 30 days, 12 months, 24 months, and 36 months

  11. Stroke (ischemic and hemorrhagic)

    Number of participants with stroke (ischemic and hemorrhagic)

    Measured: At 12, 24, and 36 months

  12. Total angioplasty procedure time

    Measured: During the index procedure

  13. Fluoroscopy time of the angioplasty procedure

    Measured: During the index procedure

  14. Contrast volume of the angioplasty procedure

    Measured: During the index procedure

  15. Number of devices (DCB/ DES) used for PCI treatment

    Measured: During the index procedure

Timeline

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

  1. First posted6 May 2023
  2. Study start7 Sep 2023
  3. Primary completionMay 2027 (estimated)
  4. Study completionJan 2029 (estimated)

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
1,436 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05846893
Sponsor's protocol ID
AAG-G-H-2124
Acronym
REVERSE
Status last verified
May 2026
First submitted
11 Apr 2023
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SeQuent® Please NEO drug-coated balloon catheter and Current-generation drug-eluting stent in people with Coronary Artery Disease and Myocardial Ischemia, run by B. Braun Medical Industries Sdn. Bhd. at 21 sites in 4 countries.

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 11 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in South Korea, Malaysia, Singapore, Taiwan. 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?

This study is still under way. Results are not available in the source record yet.

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?

Net Adverse Clinical Event (NACE) (time frame: At 1 year). 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 NCT05846893.

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 28 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in