A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease

NCT03769623 | Completed DMC

• 1 other identifier: BIO-RISE CHINA
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, multicenter, randomized, blind, parallel and superiority test study. It is planned to select 206 cases of subjects with small coronary artery vessel disease who meet the inclusion/exclusion criteria. They are randomly divide them into Biolimus release coronary balloon catheter treatment group and plain old balloon angioplasty catheter (Powerline) treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation. Follow-up with angiography is conducted at 9 months. The late lumen loss in diseased segment at 9 months after operation is the primary endpoint.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The late lumen loss

  The late lumen loss in the lesion segment 9 months after surgery

  9 months

Study Arms (2)

Biolimus

EXPERIMENTAL

BA9 Drug-eluting Coronary Artery Balloon Catheter

Device: Biolimus

Powerline

ACTIVE COMPARATOR

Balloon dilated catheter

Device: Powerline

Interventions

Biolimus DEVICE

103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus

Biolimus

Powerline DEVICE

103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline

Powerline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with stable angina pectoris, unstable angina pectoris, old myocardial infarction or silent myocardial ischemia with objective evidence;
• Subjects at the age between ≥18 and ≤75 years old;
• Subjects without contraindications of coronary revascularization (PCI or CABG);
• Subjects are willing to participate in the study, sign informed consent form, and accept angiography follow-up at 9 months after operation as well as clinical follow-up after operation and at 30 days, 6 months, 9 months and 12 months after operation.
• Target lesion is primary in-situ coronary artery disease, located on 1 or 2 different coronary artery vessels, with no more than 1 target lesion on each coronary artery vessel (in case of lesion on two vessels, 2 target lesions are allowed at most);
• Reference vessel diameter is between 2.0 mm and 2.75 mm (visual observation);
• For non-target vessel lesion, interventional therapy needs to be conducted firstly (simultaneous therapy is required). After successful therapy, it is required to conduct random and target lesion treatment;
• Preoperative diameter stenosis must be ≥70% or ≥50%, accompanied with corresponding ischemia of target vessel (visual observation);
• Each target lesion of patients in test group and control group can only be treated with one trial device (Biolimus release coronary balloon catheter) or control device (Powerline balloon angioplasty catheter).

You may not qualify if:

• Any patient with myocardial infarction within one month;
• Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease;
• Patients with cardiogenic shock;
• Patients with left ventricular ejection fraction of less than 35%;
• Female patients planned for or in pregnancy (or lactation) or male patients planned for impregnation;
• Patients with the expected lifetime of no more than 1 year or potential factors of difficulty in clinical follow-up;
• Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint, or reaching the time limit of primary endpoint but less than 3 months;
• Patients who plans to accept selective operation within 12 months;
• Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
• Patients with severe renal failure(eGFR\<30ml/minute) or such medical history, failure to comply with angiography conditions;
• Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months;
• Patients with bleeding tendency or coagulation disorders;
• Patients who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
• Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;
• Patients with other diseases (for instance, malignant tumor, organ grafting or candidate) or addiction history (such as alcohol, cocaine and heroin);

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

Location

Related Publications (1)

• Xu K, Fu G, Tong Q, Liu B, Han X, Zhang J, Ma G, Yang Q, Li H, Zhou Y, Jing Q, Li Y, Han Y. Biolimus-Coated Balloon in Small-Vessel Coronary Artery Disease: The BIO-RISE CHINA Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1219-1226. doi: 10.1016/j.jcin.2022.03.024. Epub 2022 May 25.

  PMID: 35738744 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yaling Han

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Diameter: 2.0mm, 2.25mm, 2.5mm, 2.75mm Length: 10mm, 15mm, 20mm, 25mm, 30mm

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: June 25, 2019
• Primary Completion: February 20, 2021
• Study Completion: April 6, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-08

Locations

CN (1)