Trans Radial Versus Transfemoral Route for Coronary Angiography

NCT02983721 | Completed DMC

• 2 other identifiers: car003421PG thesis 003421
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• Access time

  Access time for the procedures

  4 years

• Fluoroscopy time

  measure of radiation exposure

  4 years

• Procedure time

  time taken to do the full procedure

  4 years

• hospital stay

  time period the patient stayed in the hospital

  4 years

Secondary Outcomes (4)

• hematoma

  4 years

• pseudoaneurysm

  4 years

• bleeding

  4 years

• Access site failure

  4 years

Study Arms (2)

Transfemoral

ACTIVE COMPARATOR

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.

Procedure: transradial; Procedure: Transfemoral

Transradial

ACTIVE COMPARATOR

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.

Procedure: transradial; Procedure: Transfemoral

Interventions

transradial PROCEDURE

transradial route for coronary angiography and PCI

Transfemoral; Transradial

Transfemoral PROCEDURE

transfemoral route for coronary angiography and PCI

Transfemoral; Transradial

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnostic angiography of coronary vessels, PCI

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheri Kashmir Institute of Medical Sciences: lead

Related Publications (1)

• Bhat FA, Changal KH, Raina H, Tramboo NA, Rather HA. Transradial versus transfemoral approach for coronary angiography and angioplasty - A prospective, randomized comparison. BMC Cardiovasc Disord. 2017 Jan 11;17(1):23. doi: 10.1186/s12872-016-0457-2.

  PMID: 28077091 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Fayaz Bhat, MBBS, MD

  Ministry of Health, Jammu and Kashmir, India.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 6, 2016
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share