Back to results

Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique

Primary Purpose

Coronary Artery Disease

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Distal Radial Vascular Access

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring radial artery, distal radial artery, vascular access, radial artery occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients over 18 years
Clinical indication for coronary angiography / angioplasty
Palpable radial and distal radial pulse
Previous clinical Barbeau test
Radial and distal radial patency via vascular ultrasound
24-hour and 30-day follow-up feasibility

Exclusion Criteria:

Previous vascular punctions in the studied anatomic site
Artery introductor relationship
Arteriovenous fistula
Current treatment with oral anticoagulants
Contraindication for Heparin
Incomplete medical records
Vascular access sheath - radial artery mismatch
Distal radial or ulnar fracture history

Sites / Locations

Instituto Mexicano del Seguro Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Distal Radial Access

Proximal Radial Access

Arm Description

Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization

Proximal Radial Vascular Access prior to catheterization

Outcomes

Primary Outcome Measures

Vascular Access Time

Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed.

Secondary Outcome Measures

"Conventional" Radial Artery Occlusion

Radial Artery Occlusion using vascular ultrasound

Distal Radial Artery Occlusion

Distal Radial Artery Occlusion using vascular ultrasound

Full Information

NCT ID

NCT05066074

First Posted

September 14, 2021

Last Updated

November 16, 2021

Sponsor

Instituto Mexicano del Seguro Social

1. Study Identification

Unique Protocol Identification Number

NCT05066074

Brief Title

Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique

Official Title

Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 16, 2021 (Actual)

Primary Completion Date

March 1, 2022 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Mexicano del Seguro Social

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.

Detailed Description

Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

radial artery, distal radial artery, vascular access, radial artery occlusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised Clinical Trial - Equivalence model (Two tailed) Based on a previous pilot study: SD 97 sec Allowable Diff: 90 sec, Patient loss 15%, Type I error 2.5%, Type II error 90% Mean Differences: 0

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Distal Radial Access

Arm Type

Experimental

Arm Description

Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization

Arm Title

Proximal Radial Access

Arm Type

Active Comparator

Arm Description

Proximal Radial Vascular Access prior to catheterization

Intervention Type

Procedure

Intervention Name(s)

Distal Radial Vascular Access

Other Intervention Name(s)

dTRA

Intervention Description

Distal Radial Vascular Access

Primary Outcome Measure Information:

Title

Vascular Access Time

Description

Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed.

Time Frame

Seconds during the procedure

Secondary Outcome Measure Information:

Title

"Conventional" Radial Artery Occlusion

Description

Radial Artery Occlusion using vascular ultrasound

Time Frame

In the first 24 hours, and follow up to 30 days

Title

Distal Radial Artery Occlusion

Description

Distal Radial Artery Occlusion using vascular ultrasound

Time Frame

In the first 24 hours, and follow up to 30 days

Other Pre-specified Outcome Measures:

Title

Quality of life outcome

Description

Patient preference for the same access in case a second procedure is needed

Time Frame

30-day survey

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients over 18 years Clinical indication for coronary angiography / angioplasty Palpable radial and distal radial pulse Previous clinical Barbeau test Radial and distal radial patency via vascular ultrasound 24-hour and 30-day follow-up feasibility Exclusion Criteria: Previous vascular punctions in the studied anatomic site Artery introductor relationship Arteriovenous fistula Current treatment with oral anticoagulants Contraindication for Heparin Incomplete medical records Vascular access sheath - radial artery mismatch Distal radial or ulnar fracture history

Facility Information:

Facility Name

Instituto Mexicano del Seguro Social

City

Tijuana

State/Province

Baja California

ZIP/Postal Code

22226

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

(planned) March 2022

Learn more about this trial

Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique

We'll reach out to this number within 24 hrs