N/A
N=300
DIstal vs Proximal Radial Artery Access for Cath
Coronary Angiography · Coronary Angioplasty
Bottom Line
View on ClinicalTrials.gov: NCT04318990 ↗Enrolled (actual)
300
Serious AEs
1.7%
Results posted
May 2024
Primary outcome: Primary: Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100) — 0; 0 DASH Score change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Distal radial artery access (Procedure); Proximal radial artery surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor Research Institute
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100) |
0; 0 | — |
| PRIMARY Thumb and Forefinger Pinch Strength Test |
-0.1; -0.3 | — |
| PRIMARY Hand Grip Strength Test |
0.7; 1.3 | — |
| SECONDARY Re-intervention Using the Radial Artery |
5; 8 | — |
| SECONDARY Radial Artery Occlusion |
0; 2; 0; 1; 112; 101 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years.
- The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound.
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation
Exclusion Criteria
- Obligatory femoral or forearm radial access
- Previous ipsilateral forearm radial artery occlusion.
- Patient on therapeutic oral anticoagulation.
- Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands.
- Enrolment in another study that competes or interferes with this study.
- Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
- Subject with planned complex PCI or procedure necessitating multiple intervention.
- 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.
- History of stroke with residual deficit that affects hand function.
- Previous radial artery catheterization within 1 year.
Data sourced from ClinicalTrials.gov (NCT04318990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.