DIstal vs Proximal Radial Artery Access for Cath

Not Applicable

Completed

• Conditions: Coronary Angiography; Coronary Angioplasty
• Interventions: Procedure: Distal radial artery access; Procedure: Proximal radial artery surgery

• 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

Arm && Interventions

Group	Intervention	Description
Distal radial artery access	Distal radial artery access	Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Proximal radial artery access	Proximal radial artery surgery	Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.

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