Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biolimus Coated Coronary Artery Balloon Dilation Catheter.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device Biolimus Coated Coronary Artery Balloon Dilation Catheter
Patients with Coronary Artery Disease will be treated with Biolimus Coated Coronary Artery Balloon Dilation Catheter
Primary outcome measures
- Target lesion failure rate (TLF) [Time frame: 12 months after surgery]
Secondary outcome measures (5)
- Interventional success rate [Time frame: Immediately after operation]
- Device-related cardiovascular clinical composite endpoint [Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24]
- Patient-related cardiovascular clinical composite endpoint [Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24]
- Major adverse cardiac events (MACEs) [Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24]
- Incidence of thrombotic events as defined by ARC [Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06385067 · JW-PM-DCB-2024