Drug-coated Balloon Treatment in Coronary Lesions
Immediate and Midterm Clinical Outcome of Drug Coated Balloon Angioplasty in Different Coronary Artery Lesions in Sohag Governorate
1 other identifier
interventional
100
1 country
1
Brief Summary
This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2024
CompletedStudy Start
First participant enrolled
February 10, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2025
CompletedFebruary 20, 2024
February 1, 2024
4 months
February 4, 2024
February 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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. 1. 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. 2. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
6 months
Study Arms (1)
Control
EXPERIMENTALInterventions
Drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions
Eligibility Criteria
You may qualify if:
- Eligible patients are those with lesions in the coronary vessel tree who will be planned to be treated with drug coated balloon.
You may not qualify if:
- Severe renal impairment ( Cr.Cl. \< 45 ml/min ).
- Sever heart failure or liver cell failure .
- Patients with contraindications to coronary angiography or invasive procedures.
- Known allergy or intolerance to the medications or devices commonly used during PCI procedures.
- Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag faculty of medicine
Sohag, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sharaf Eldin Shazly, PHD
Sohag faculty of medicine
- STUDY CHAIR
Mohammed Abdelwahab, PHD
Sohag faculty of medicine
- PRINCIPAL INVESTIGATOR
Imran Saber, MA
Sohag faculty of medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
February 4, 2024
First Posted
February 20, 2024
Study Start
February 10, 2024
Primary Completion
June 10, 2024
Study Completion
February 10, 2025
Last Updated
February 20, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share