Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Sheri Kashmir Institute of Medical Sciences
- Enrollment
- 400
- Primary Endpoint
- Fluoroscopy time
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study was to assess and compare the feasibility, success and safety of Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital, Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of vessel, MACE, Stroke and others.
Detailed Description
Background: PCI has been done traditionally through transfemoral route. But now transradial and transbrachial routes are also coming up in practice. We compared transradial versus transfemoral routes for ease of operability, time for procedure, complications, and failure rates through a prospective study. Methods: 400 Patients admitted in department of cardiology for percutaneous interventions were enrolled in the study. 200 patients were assigned to each group randomly. A single team did all the procedures. Pre procedure, intra procedure and post procedure data of all the patients was collected, tabulated and analysed properly. The variables studied include Access time ,Fluoroscopy time and overall procedure time, post procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed), Failure rates,post procedure myocardial infarction, stroke, acute renal failure and infections.
Investigators
Khalid Changal
Principal Investigator
Sheri Kashmir Institute of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •diagnostic angiography of coronary vessels, PCI
Exclusion Criteria
- •Patients with impaired renal function tests.
- •Lack of informed consent.
- •Severe infection.
- •Previous contrast allergy.
- •Severe intrinsic/iatrogenic caogulopathy INR\>
- •Abnormal modified Allen's test.
Outcomes
Primary Outcomes
Fluoroscopy time
Time Frame: 4 years
measure of radiation exposure
Access time
Time Frame: 4 years
Access time for the procedures
Procedure time
Time Frame: 4 years
time taken to do the full procedure
hospital stay
Time Frame: 4 years
time period the patient stayed in the hospital
Secondary Outcomes
- pseudoaneurysm(4 years)
- Access site failure(4 years)
- hematoma(4 years)
- bleeding(4 years)