DIstal vs Proximal Radial Artery Access for Cath

Not Applicable

Completed

• Conditions: Coronary Angiography; Coronary Angioplasty

• Registration Number: NCT04318990
• Lead Sponsor: Baylor Research Institute

Brief Summary

This single-center, prospective, randomized study will evaluate distal radial artery (dRA) vs. proximal radial artery access (pRA) in regards to hand function and radial artery occlusion.

Detailed Description

Primary objective is to evaluate hand function following distal radial artery access compared to proximal artery access in patients undergoing cardiac catheterization.

Hand function will be assessed by:

* QuickDASH questionnaire

* Hand grip test

* Thumb forefinger pinch test utilizing a pinch gauge

Secondary objectives: Vascular access success rates, hematoma, bleeding, complications of vascular access and radial artery occlusion.

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-06
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-24
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Results First Submitted: 2023-11-16
• Results First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Results First Posted: 2024-05-03
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Age ≥ 18 years.
2. The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound.
3. Patient should be able to comply with the protocol.
4. Provide written informed consent before study participation

Exclusion Criteria

1. Obligatory femoral or forearm radial access
2. Previous ipsilateral forearm radial artery occlusion.
3. Patient on therapeutic oral anticoagulation.
4. Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands.
5. Enrolment in another study that competes or interferes with this study.
6. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
7. Subject with planned complex PCI or procedure necessitating multiple intervention.
8. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
9. History of stroke with residual deficit that affects hand function.
10. Previous radial artery catheterization within 1 year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)	1 year	Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)
Thumb and Forefinger Pinch Strength Test	1 year	Hand function: Thumb and forefinger pinch strength (kg)
Hand Grip Strength Test	1 month	Hand grip strength test (kg)

Secondary Outcome Measures

Name	Time	Method
Radial Artery Occlusion	1 year	Occurrence of distal radial artery occlusion and proximal radial artery occlusion for patients who had distal or proximal radial artery access
Re-intervention Using the Radial Artery	1 year	Patients who required re-intervention using the radial artery up to 1 year following the initial intervention

Trial Locations

Locations (1)

Baylor Scott & White The Heart Hospital - Plano; 🇺🇸 Plano, Texas, United States