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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

Tracking Information
First Submitted Date  ICMJE December 5, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date December 7, 2018
Estimated Study Start Date  ICMJE December 31, 2018
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
The late lumen loss [ Time Frame: 9 months ]
The late lumen loss in the lesion segment 9 months after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of Biolimus in the Treatment of Patients With Small Coronary Artery Disease
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Biolimus
    BA9 Drug-eluting Coronary Artery Balloon Catheter
    Intervention: Device: Biolimus
  • Active Comparator: Powerline
    Balloon dilated catheter
    Intervention: Device: Powerline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
206
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jingjing Wang, Master 18910979806 jingjing.wang@jwmsgrp.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769623
Other Study ID Numbers  ICMJE Brave-20181001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JW Medical Systems Ltd
Study Sponsor  ICMJE JW Medical Systems Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account JW Medical Systems Ltd
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP