Trans Radial Versus Transfemoral Route for Coronary Angiography

Coronary Artery Disease Clinical Trial

Official title:

Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983721
• Other study ID #: car003421
• Secondary ID: PG thesis 003421
• Status: Completed
• Phase: N/A
• First received: December 1, 2016
• Last updated: December 2, 2016
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: December 2016
• Source: Sheri Kashmir Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• transradial
transradial route for coronary angiography and PCI
• Transfemoral
transfemoral route for coronary angiography and PCI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheri Kashmir Institute of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Access time	Access time for the procedures	4 years	No
Primary	Fluoroscopy time	measure of radiation exposure	4 years	No
Primary	Procedure time	time taken to do the full procedure	4 years	No
Primary	hospital stay	time period the patient stayed in the hospital	4 years	No
Secondary	hematoma	hematoma development at the site of puncture	4 years	No
Secondary	pseudoaneurysm	local complication at the access site	4 years	No
Secondary	bleeding	at the access site	4 years	No
Secondary	Access site failure	failure to gain access for the procedure	4 years	No