CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess

NCT04194606 | Unknown

• 1 other identifier: CORRECT Radial RCT 2019
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Angiography; Coronary Artery Disease

Keywords

Anatomical snuffbox; Percutaneous coronary intervention; Radial access; Distal radial access; Radial artery occlusion; Coronary catheterization; Radial artery

Outcome Measures

Primary Outcomes (1)

• Lower rate of forearm radial artery occlusion (RAO)

  Use of color doppler ultrasound to assess the patency of the radial artery used in the index procedure.

  30 days

Secondary Outcomes (7)

• Puncture success rate of the randomized puncture site

  During the procedure

• Access cross over rate

  During the procedure

• Duration of puncture

  During the procedure

• Hematoma, bleeding and other complications

  48 hours

• Use of standard questionaire to assess pain

  30 days

Study Arms (2)

Forearm radial access

ACTIVE COMPARATOR

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

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

Distal radial access

EXPERIMENTAL

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

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

Interventions

Use of radial artery for access for a coronary angiography or intervention 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 After the procedure is finished the sheath will be withdrawn and a standard closure device will be applied to achieve hemostasis.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; Forearm radial access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. med. Karsten Schenke: lead
• Asklepios proresearch: collaborator

Study Sites (3)

Klinikum Landkreis Erding

Erding, Bavaria, 85435, Germany

NOT YET RECRUITING

Sana Kliniken Düsseldorf GmbH

Düsseldorf, North Rhine-Westphalia, 40953, Germany

NOT YET RECRUITING

Asklepios Klinik Barmbek

Hamburg, 22291, Germany

RECRUITING

Related Publications (1)

• Schenke K, Prog R, Joghetaei N, Sood N, Viertel A, Matthiesen T, Bott-Flugel L, Ohm S, Dill T, Gronefeld G. CORRECT RADIAL RCT. CORonaRy angiography and intErventions via distal vs proximal transradial aCcess-a randomized Trial of different RADIAL puncture sites. Clin Res Cardiol. 2026 Jan;115(1):99-111. doi: 10.1007/s00392-025-02759-5. Epub 2025 Nov 24.

  PMID: 41284047 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Arterial Occlusive Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Karsten Schenke, MD

  Asklepios Klinik Bambek Hamburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karsten Schenke, MD

CONTACT

+49401818824811; k.schenke@asklepios.com

Gerian Grönefeld, MD

CONTACT

+49401818824811; g.groenefeld@asklepios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oberarzt - Consultant

Model Details: Prospective, multicenter, open Label randomized controlled trial

Study Record Dates

• First Submitted: December 7, 2019
• First Posted: December 11, 2019
• Study Start: January 14, 2020
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)