Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilat… (NCT06385067) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
400 participantsStarted 2024-05-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.