CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess

NCT ID: NCT04194606

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2024-12-31

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.

Conditions

Coronary Angiography; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Forearm radial access

Patients who undergo coronary angiography or intervention by forearm radial artery access

Group Type: ACTIVE_COMPARATOR

Use of radial artery for access for a coronary angiography or intervention

Intervention Type: PROCEDURE

After puncture of the radial artery in either the area of the anatomical snuffbox or the lower forearm following modified Seldinger technique a sheath will be advanced and a CAG or PCI will be performed. After the procedure is finished the sheath will be withdrawn and a standard closure device will be applied to achieve hemostasis. The choice of the patients side, the sheath, the catheters and the closing device will be at the discretion of the interventionalist.

Distal radial access

Patients who undergo coronary angiography or intervention by accessing the distal radial artery in the area of the anatomical snuff-box

Group Type: EXPERIMENTAL

Use of radial artery for access for a coronary angiography or intervention

Intervention Type: PROCEDURE

After puncture of the radial artery in either the area of the anatomical snuffbox or the lower forearm following modified Seldinger technique a sheath will be advanced and a CAG or PCI will be performed. After the procedure is finished the sheath will be withdrawn and a standard closure device will be applied to achieve hemostasis. The choice of the patients side, the sheath, the catheters and the closing device will be at the discretion of the interventionalist.

Interventions

Use of radial artery for access for a coronary angiography or intervention

After puncture of the radial artery in either the area of the anatomical snuffbox or the lower forearm following modified Seldinger technique a sheath will be advanced and a CAG or PCI will be performed. After the procedure is finished the sheath will be withdrawn and a standard closure device will be applied to achieve hemostasis. The choice of the patients side, the sheath, the catheters and the closing device will be at the discretion of the interventionalist.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asklepios proresearch

INDUSTRY

Sponsor Role: collaborator

Dr. med. Karsten Schenke

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Karsten Schenke

Oberarzt - Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Karsten Schenke, MD

Role: PRINCIPAL_INVESTIGATOR

Asklepios Klinik Bambek Hamburg

Locations

Klinikum Landkreis Erding

Erding, Bavaria, Germany

Site Status: NOT_YET_RECRUITING

Sana Kliniken Düsseldorf GmbH

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: NOT_YET_RECRUITING

Asklepios Klinik Barmbek

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Karsten Schenke, MD

Role: CONTACT

k.schenke@asklepios.com

+49401818824811

Gerian Grönefeld, MD

Role: CONTACT

g.groenefeld@asklepios.com

+49401818824811

Facility Contacts

Nader Joghetaei, MD

Role: primary

nader.joghetaei@klinikum-erding.de

+49 8122 59-1760

Rostyslav Prog, MD

Role: primary

rostyslav.prog@sana.de

+49 211 997 24656

Karsten Schenke, MD

Role: primary

k.schenke@asklepios.com

+49401818828381

Achim Viertel, MD

Role: backup

a.viertel@asklepios.com

+49401818826457

Other Identifiers

CORRECT Radial RCT 2019

Identifier Type: -

Identifier Source: org_study_id