Clinical trial NCT06385067: Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
Official title: Prospective, International Multicenter Clinical Study Evaluating the Safety and Efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter (BioAscend) in the Treatment of Primary Coronary Artery Disease in the Real World
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: JW Medical Systems Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;

Brief summary: The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.

The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.

Detailed description: Study Design:

1. Prospective, international multi-center clinical study;
2. It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;
3. In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis.
4. Register and collect data using the EDC system;
5. Enrollment method: competitive enrollment;
6. Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm;
* Patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type B dissection; Patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol.

Exclusion Criteria:

* Pregnant or lactating females;
* Patients with cardiogenic shock;
* Patients with severe congestive heart failure or severe heart failure with NYHA class IV;
* Patients with severe valvular heart disease;
* Patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult;
* Patients who are considered unsuitable for inclusion by the investigator for other reasons.
* Those who are known to be allergic to melcrolimus and contrast media.

Primary outcomes:
measure: Target lesion failure rate (TLF)
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Interventional success rate
timeFrame: Immediately after operation
measure: Device-related cardiovascular clinical composite endpoint
timeFrame: From postoperative to before discharge, day 30, month 6, month 12, month 24
measure: Patient-related cardiovascular clinical composite endpoint
timeFrame: From postoperative to before discharge, day 30, month 6, month 12, month 24
measure: Major adverse cardiac events (MACEs)
timeFrame: From postoperative to before discharge, day 30, month 6, month 12, month 24
measure: Incidence of thrombotic events as defined by ARC
timeFrame: From postoperative to before discharge, day 30, month 6, month 12, month 24
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Lang Li
role: PRINCIPAL_INVESTIGATOR
References: