Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Biolimus Coated Coronary Artery Balloon Dilation Catheter
  Patients with Coronary Artery Disease will be treated with Biolimus Coated Coronary Artery Balloon Dilation Catheter

Первичные конечные точки

• Target lesion failure rate (TLF) [Срок оценки: 12 months after surgery]

Вторичные конечные точки (5)

• Interventional success rate [Срок оценки: Immediately after operation]
• Device-related cardiovascular clinical composite endpoint [Срок оценки: From postoperative to before discharge, day 30, month 6, month 12, month 24]
• Patient-related cardiovascular clinical composite endpoint [Срок оценки: From postoperative to before discharge, day 30, month 6, month 12, month 24]
• Major adverse cardiac events (MACEs) [Срок оценки: From postoperative to before discharge, day 30, month 6, month 12, month 24]
• Incidence of thrombotic events as defined by ARC [Срок оценки: From postoperative to before discharge, day 30, month 6, month 12, month 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06385067 · JW-PM-DCB-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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