Trans Radial Versus Transfemoral Route for Coronary Angiography

NCT ID: NCT02983721

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

transradial

Intervention Type PROCEDURE

transradial route for coronary angiography and PCI

Transfemoral

Intervention Type PROCEDURE

transfemoral route for coronary angiography and PCI

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.

Group Type ACTIVE_COMPARATOR

transradial

Intervention Type PROCEDURE

transradial route for coronary angiography and PCI

Transfemoral

Intervention Type PROCEDURE

transfemoral route for coronary angiography and PCI

Interventions

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transradial

transradial route for coronary angiography and PCI

Intervention Type PROCEDURE

Transfemoral

transfemoral route for coronary angiography and PCI

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheri Kashmir Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Khalid Changal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fayaz Bhat, MBBS, MD

Role: STUDY_CHAIR

Ministry of Health, Jammu and Kashmir, India.

References

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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.

Reference Type DERIVED
PMID: 28077091 (View on PubMed)

Other Identifiers

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PG thesis 003421

Identifier Type: OTHER

Identifier Source: secondary_id

car003421

Identifier Type: -

Identifier Source: org_study_id