CORRECT RADIAL RCT: CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess - a Randomized Trial of Different Radial Puncture Sites
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 3
- Primary Endpoint
- Lower rate of forearm radial artery occlusion (RAO)
Study Overview
Brief Summary
The objective of the study is to determine that a coronary angiography (CAG) or percutaneous coronary intervention (PCI) via a distal puncture of the radial artery (distal transradial access, dTRA) leads to a lower rate of radial artery occlusion (RAO) while also showing that it has a similar success rate when compared to the traditional proximal (proximal transradial access, pTRA) puncture site.
Detailed Description
Cardiac catheterization is one of the most common invasive procedures worldwide. After demonstrating the superiority of the radial access over the femoral arterial approach, the radial artery puncture has become the first choice for elective and emergency coronary interventions. In addition to the often chosen access on the inside of the forearm, the course of the radial artery also allows a puncture further distal on the back of the hand. In the anatomical snuffbox, the diameter is still sufficient for the introduction of the usual sheath, however, the thrombogenic puncture at the proximal radial segment is avoided and a hemostasis by compression over the scaphoid is simplified.
This study is a prospective, open-label, randomized, multicenter study to systematically compare primary success rates and potential complications after distal transradial coronary angiography or coronary intervention versus proximal radial artery puncture over the wrist. Both puncture routes are well established in clinical routine and are used in both elective and emergency cardiac catheterization in the centers involved and worldwide. Systematic comparisons exist so far only in small series, but randomized and prospective data would be urgently needed in the frequent application. Both puncture sites are only 4-8 cm apart, so that many risks of a transradial examination (vascular injury and / or closure, perforation, spasm) are in principle common to both access sites.
The purpose of this study is to demonstrate the potential benefits of radial artery puncture in the back of the hand due to a reduced rate of chronic vascular occlusion compared to over the wrist, as well as complications (bleeding or nerve damage) and subjective tolerability ( Pain) systematically.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written consent to participate in the study
- •Age ≥ 18 years
- •Indication for coronary angiography or coronary intervention
- •Palpable pulse of the proximal and distal radial artery on one or both arms
Exclusion Criteria
- •Hemodynamic instability (according to the criteria of cardiogenic shock: Hf> 120 / min and RR syst <90 mmHg)
- •Intubated patients
- •Sonographic evidence of occlusion of both radial arteries
- •Pregnant or lactating women
- •Patients that are currently or have within the last 30 days participated in a clinical trial
- •Primarily planned bilateral radial access; e.g. in the context of a CTO recanalization
- •Patients who are in a dependency / employment/ relationship with the study doctor or center
- •Patients with bilateral hand or arm misalignment / paresis that makes a radial Access impossible
- •Patients who do not speak German or who are unable to understand the nature, significance or scope of the study
Arms & Interventions
Forearm radial access
Patients who undergo coronary angiography or intervention by forearm radial artery access
Intervention: Use of radial artery for access for a coronary angiography or intervention (Procedure)
Distal radial access
Patients who undergo coronary angiography or intervention by accessing the distal radial artery in the area of the anatomical snuff-box
Intervention: Use of radial artery for access for a coronary angiography or intervention (Procedure)
Outcomes
Primary Outcomes
Lower rate of forearm radial artery occlusion (RAO)
Time Frame: 30 days
Use of color doppler ultrasound to assess the patency of the radial artery used in the index procedure.
Secondary Outcomes
- Incidence of vasospasm(during the procedure)
- Puncture success rate of the randomized puncture site(During the procedure)
- Hematoma, bleeding and other complications(48 hours)
- Use of standard questionaire to assess Hand function(30 days)
- Access cross over rate(During the procedure)
- Duration of puncture(During the procedure)
- Use of standard questionaire to assess pain(30 days)
Investigators
Dr. med. Karsten Schenke
Oberarzt - Consultant
Asklepios Kliniken Hamburg GmbH