Trans Radial Versus Transfemoral Route for Coronary Angiography

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• 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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-12
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-02
• Last Update Submitted: 2016-12-02
• Study First Posted: 2016-12-06
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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>2.
  • Abnormal modified Allen's test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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