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Trans Radial Versus Transfemoral Route for Coronary Angiography

Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02983721
Enrollment
400
Registered
2016-12-06
Start date
2011-08-31
Completion date
2015-08-31
Last updated
2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

PROCEDUREtransradial

transradial route for coronary angiography and PCI

PROCEDURETransfemoral

transfemoral route for coronary angiography and PCI

Sponsors

Sheri Kashmir Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
hospital stay4 yearstime period the patient stayed in the hospital
Access time4 yearsAccess time for the procedures
Fluoroscopy time4 yearsmeasure of radiation exposure
Procedure time4 yearstime taken to do the full procedure

Secondary

MeasureTime frameDescription
hematoma4 yearshematoma development at the site of puncture
pseudoaneurysm4 yearslocal complication at the access site
bleeding4 yearsat the access site
Access site failure4 yearsfailure to gain access for the procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026