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

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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.

Locations
Other Locations
Malaysia
Sultan Idris Shah Serdang Hospital
RECRUITING
Kajang
Queen Elizabeth II Hospital
RECRUITING
Kota Kinabalu
Cardiac Vascular Sentral Kuala Lumpur
RECRUITING
Kuala Lumpur
National Heart Institute Malaysia
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Sarawak Heart Center
RECRUITING
Kuching
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan-si
Gyeongsang National University Changwon Hospital
RECRUITING
Changwon
Kangwon National University Hospital
RECRUITING
Chuncheon
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Ulsan University Hospital
RECRUITING
Donggu
Inje University Ilsan Paik Hospital
RECRUITING
Goyang-si
Kangbuk Samsung Hospital
RECRUITING
Seoul
Singapore
Tan Tock Seng Hospital
RECRUITING
Novena
Khoo Teck Puat Hospital
RECRUITING
Singapore
National Heart Centre Singapore
RECRUITING
Singapore
Taiwan
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
Chang Gung Memorial Hospital
NOT_YET_RECRUITING
Taoyuan District
Contact Information
Primary
Hooi Sian Eng, Ph.D
hooi.eng@bbraun.com
+60-12-428-2880
Backup
Philip Steen, MD
philip.steen@bbraun.com
+49-30-568207-124
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2028-09
Participants
Target number of participants: 1436
Treatments
Experimental: SeQuent® Please NEO drug-coated balloon catheter
Experimental: Current-generation drug-eluting stent
Sponsors
Collaborators: Universität des Saarlandes, Seoul National University Hospital, B. Braun Melsungen AG, Ulsan University Hospital, European Cardiovascular Research Center
Leads: B. Braun Medical Industries Sdn. Bhd.

This content was sourced from clinicaltrials.gov