Drug-coated Balloon Clinical Trial
Official title:
Immediate and Midterm Clinical Outcome of Drug Coated Balloon Angioplasty in Different Coronary Artery Lesions in Sohag Governorate
This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | February 10, 2025 |
Est. primary completion date | June 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Eligible patients are those with lesions in the coronary vessel tree who will be planned to be treated with drug coated balloon. Exclusion Criteria: 1. Severe renal impairment ( Cr.Cl. < 45 ml/min ). 2. Sever heart failure or liver cell failure . 3. Patients with contraindications to coronary angiography or invasive procedures. 4. Known allergy or intolerance to the medications or devices commonly used during PCI procedures. 5. Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol. 6. Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
Egypt | Sohag faculty of medicine | Sohag |
Lead Sponsor | Collaborator |
---|---|
Sohag University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiac events at 6 months | Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding [BARC type 3 to 5]) at 6 months.
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. |
6 months |
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