Clinical trial NCT02983721: Trans Radial Versus Transfemoral Route for Coronary Angiography
Official title: Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Sheri Kashmir Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Access time
timeFrame: 4 years
measure: Fluoroscopy time
timeFrame: 4 years
measure: Procedure time
timeFrame: 4 years
measure: hospital stay
timeFrame: 4 years
Secondary outcomes:
measure: hematoma
timeFrame: 4 years
measure: pseudoaneurysm
timeFrame: 4 years
measure: bleeding
timeFrame: 4 years
measure: Access site failure
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Ministry of Health, Jammu and Kashmir, India.
name: Fayaz Bhat, MBBS, MD
role: STUDY_CHAIR
References:
citation: 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.