Trans Radial Versus Transfemoral Route for Coronary Angiography
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: transradialProcedure: Transfemoral
- Registration Number
- NCT02983721
- Lead Sponsor
- Sheri Kashmir Institute of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- diagnostic angiography of coronary vessels, PCI
-
Patients with impaired renal function tests.
- Lack of informed consent.
- Severe infection.
- Previous contrast allergy.
- Severe intrinsic/iatrogenic caogulopathy INR>2.
- Abnormal modified Allen's test.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transfemoral transradial in case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route. Transfemoral Transfemoral in case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route. Transradial Transfemoral Our preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance. Transradial transradial Our preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance.
- Primary Outcome Measures
Name Time Method Fluoroscopy time 4 years measure of radiation exposure
Access time 4 years Access time for the procedures
Procedure time 4 years time taken to do the full procedure
hospital stay 4 years time period the patient stayed in the hospital
- Secondary Outcome Measures
Name Time Method pseudoaneurysm 4 years local complication at the access site
Access site failure 4 years failure to gain access for the procedure
hematoma 4 years hematoma development at the site of puncture
bleeding 4 years at the access site