Status:
UNKNOWN
The Safety and Efficacy of Biolimus in the Treatment of Patients With in Stent Restenosis
Lead Sponsor:
JW Medical Systems Ltd
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study consisted of a randomized controlled trial group and a long balloon observation group. In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited a...
Detailed Description
This study consisted of a randomized controlled trial group and a long balloon observation group. In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited a...
Eligibility Criteria
Inclusion
- 1\. 18 years ≤ subject age ≤80 years;
- 2\. Stable angina pectoris, acute coronary syndrome, old myocardial infarction or proven asymptomatic myocardial ischemia;
- 3\. Subjects have no contraindications to coronary revascularization (PCI or CABG); -4. Subjects agreed to receive clinical follow-up at discharge, 1 month, 6 months, 9 months, 1 year, 2 years and 3 years after surgery, and angiographic follow-up at 9 months after surgery;
- 5\. Subjects can understand the purpose of the study and have sufficient compliance with the study protocol. And willing to sign the informed consent and accept the risks and benefits stated in the informed consent.
Exclusion
- 1\. Patients with any myocardial infarction within 1 week, or patients whose myocardial enzyme CK or CK-MB has not returned to normal although myocardial infarction has occurred for more than 1 week;
- 2\. Patients with severe congestive heart failure (NYHA IV) or severe valvular heart disease;
- 3\. Female patients who are planning or are pregnant (or breastfeeding);
- 4\. Patients with severe renal failure with creatinine \>2.0 mg/dL (177 mol/L);
- 5\. Left ventricular ejection fraction \<30%;
- 6\. Coagulation disorders, platelet count \<100×109/ L;
- 7\. Patients with cardiogenic shock;
- 8\. Patients with concomitant diseases requiring cytoinhibitor or radiotherapy;
- 9\. Patients who are known to be allergic to aspirin, clopidogrel, Gracilis, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel, or Ticagrelor;
- 10\. Patients with bleeding constitution or a history of cerebral hemorrhage, active digestive ulcer, or gastrointestinal bleeding in the past 6 months will be restricted or prohibited to use anticoagulant therapy or anticoagulant drugs;
- 11\. Patients with a life expectancy of less than 1 year or with underlying factors of difficult clinical follow-up;
- 12\. Patients who are participating in any other clinical trial;
- 13\. For other reasons, the researchers considered the patients unsuitable for inclusion.
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04733443
Start Date
December 17 2020
End Date
February 18 2025
Last Update
November 18 2023
Active Locations (1)
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1
The First Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, China, 100039