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The Safety and Efficacy of Biolimus in the Treatment of Patients With Small Coronary Artery Disease (Brave)

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ClinicalTrials.gov Identifier: NCT03769623
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
JW Medical Systems Ltd

Brief Summary:
The study was a prospective, multicenter, randomized, blind, parallel positive control, and superiority test study, 206 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were randomly assigned to the treatment group of Biolimus and Powerline at 1:1. All subjects underwent clinical follow-up at 30 days, 6 months, 9 months, and 12 months after surgery, and angiographic follow-up at 9 months. The primary endpoint was late lumen loss at 9 months.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Biolimus Device: Powerline Not Applicable

Detailed Description:

The study was a prospective, multicenter, randomized, blind, parallel positive control, and superiority test study, 206 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were randomly assigned to the treatment group of Biolimus and Powerline at 1:1. All subjects underwent clinical follow-up at 30 days, 6 months, 9 months, and 12 months after surgery, and angiographic follow-up at 9 months. The primary endpoint was late lumen loss at 9 months.

The study will enroll 206 subjects. The sample size determination process is as follows:

According to the primary endpoint- the sample size was calculated for late lumen loss (LLL) in lesion segments 9 months after surgery. After literature review, according to a meta-analysis of 11 randomized controlled studies, in the control group (POBA), the level of late lumen loss after treatment of small vessel lesions was 0.54mm, another meta-analysis showed that LLL after PTCA was 0.57±0.57mm. According to the literature and clinical practice, clinical researchers and statisticians assumed that the level of LLL in the experimental group of this study (DCB) could be reduced to 0.32mm after treatment, and the standard deviation of the combined LLL in the two groups was conservatively estimated to be 0.50mm. The sample size calculation formula of parallel design and superiority test was used, When significant level α is taken as 0.025 on one side, power (1-β) is taken as 80%, and the superiority boundary value is 0, random allocation is carried out according to the ratio of 1:1, and the required sample size of each group is calculated as 82 cases,taking into account the maximum 20% failure rate of angiographic follow-up (as well as other causes of early exit and randomization destruction, etc.), the total sample size of the two groups was 206 cases, including 103 cases in the experimental group (DCB) and 103 cases in the control group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Blind, Parallel Positive Control, Multicenter Clinical Study Comparing the Safety and Efficacy of Release Balloon Catheters (Biolimus) With Powerline in the Treatment of Patients With Small Coronary Artery Disease
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biolimus
BA9 Drug-eluting Coronary Artery Balloon Catheter
Device: Biolimus
103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus

Active Comparator: Powerline
Balloon dilated catheter
Device: Powerline
103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline




Primary Outcome Measures :
  1. The late lumen loss [ Time Frame: 9 months ]
    The late lumen loss in the lesion segment 9 months after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with stable angina, unstable angina, or old myocardial infarction or asymptomatic ischemia with objective evidence;
  2. Age ≥18 years and ≤ 75 years;
  3. Subjects had no contraindication of coronary artery revascularization (PCI or CABG);
  4. The subjects voluntarily participated in and agreed to sign the informed consent form, and voluntarily received angiographic follow-up at 9 months after surgery and clinical follow-up at 1,6, 9 and 12 months after surgery , as required by the program.

Exclusion Criteria:

  1. The target lesion is primary and in situ coronary artery lesion located on one or two different coronary arteries, the number of target lesions on each coronary artery should not exceed one (In the case of 2 vascular lesions, a maximum of 2 target lesions are allowed);
  2. Visual reference diameter of the vessel is 2.0 mm-2.75 mm;
  3. Non-target vessel lesions should be treated with interventional therapy first (concurrent treatment is required), and then random and target lesions should be treated after successful treatment;
  4. Preoperative diameter stenosis must be greater than 70% or 50% and be accompanied by ischemia corresponding to the target vessel (visual measurement);
  5. Patients in the experimental group and the control group were treated with only one research device (Biolimus) or a control device (Powerline) for each target lesion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769623


Contacts
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Contact: Jingjing Wang, Master 18910979806 jingjing.wang@jwmsgrp.com

Locations
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China, Liaoning
Shenyang Nothern Hospital Not yet recruiting
Shenyang, Liaoning, China, 110016
Contact: Yalin Han, Ph.D         
Principal Investigator: Yaling Han, Ph.D         
Sponsors and Collaborators
JW Medical Systems Ltd

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Responsible Party: JW Medical Systems Ltd
ClinicalTrials.gov Identifier: NCT03769623     History of Changes
Other Study ID Numbers: Brave-20181001
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases