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Completed

NCT Number: NCT02983721

Trans Radial Versus Transfemoral Route for Coronary Angiography

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.

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Key information

Conditions

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

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transradial

Procedure

transradial route for coronary angiography and PCI

Transfemoral

Procedure

transfemoral route for coronary angiography and PCI

Primary outcomes

  1. Access time

    Time frame: 4 years

    Access time for the procedures

  2. Fluoroscopy time

    Time frame: 4 years

    measure of radiation exposure

  3. Procedure time

    Time frame: 4 years

    time taken to do the full procedure

  4. hospital stay

    Time frame: 4 years

    time period the patient stayed in the hospital

Secondary outcomes

  1. hematoma

    Time frame: 4 years

    hematoma development at the site of puncture

  2. pseudoaneurysm

    Time frame: 4 years

    local complication at the access site

  3. bleeding

    Time frame: 4 years

    at the access site

  4. Access site failure

    Time frame: 4 years

    failure to gain access for the procedure

Sponsors and collaborators

Lead sponsor

Sheri Kashmir Institute of Medical Sciences

Other

Registry information

Official study title

Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2016
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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