CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess (CORRECT Radial)

CORRECT RADIAL RCT: CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess - a Randomized Trial of Different Radial Puncture Sites

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Angiography
• Intervention / Treatment: Procedure: Use of radial artery for access for a coronary angiography or intervention

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karsten Schenke, MD; Phone Number: +49401818824811; Email: k.schenke@asklepios.com
• Study Contact Backup: Name: Gerian Grönefeld, MD; Phone Number: +49401818824811; Email: g.groenefeld@asklepios.com

Study Locations

• Germany
  • Hamburg, Germany, 22291
    • Recruiting
    • Asklepios Klinik Barmbek
    • Contact: Karsten Schenke, MD; Phone Number: +49401818828381; Email: k.schenke@asklepios.com
    • Contact: Achim Viertel, MD; Phone Number: +49401818826457; Email: a.viertel@asklepios.com
    • Sub-Investigator: Gerian Groenefeld, MD
    • Sub-Investigator: Achim Viertel, MD
    • Principal Investigator: Karsten Schenke, MD
  • Bavaria
    • Erding, Bavaria, Germany, 85435
      • Not yet recruiting
      • Klinikum Landkreis Erding
      • Contact: Nader Joghetaei, MD; Phone Number: +49 8122 59-1760; Email: nader.joghetaei@klinikum-erding.de
      • Principal Investigator: Nader Joghetaei, MD
  • NRW
    • Düsseldorf, NRW, Germany, 40953
      • Not yet recruiting
      • Sana Kliniken Düsseldorf GmbH
      • Contact: Rostyslav Prog, MD; Phone Number: +49 211 997 24656; Email: rostyslav.prog@sana.de
      • Principal Investigator: Rostyslav Prog, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Forearm radial access; 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; 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.
Experimental: Distal radial access; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture success rate of the randomized puncture site	Comparison of the rate of successful Insertion of the sheath in each group	During the procedure
Access cross over rate	Comparison of the rate of access site cross over in each group to complete the planned procedure	During the procedure
Duration of puncture	Exact measurement of the duration of the puncture in seconds	During the procedure
Hematoma, bleeding and other complications	Registration of complications associated with the procedure, hematoma size, bleeding according to the BARC Score	48 hours
Use of standard questionaire to assess pain	Visual analog scale is used to assess pain	30 days
Incidence of vasospasm	The incidence of vasospasm that necessitates additional medication or Forces Access site cross over is registered	during the procedure
Use of standard questionaire to assess Hand function	QuickDASH questionaire is used to assess Hand function	30 days

Collaborators and Investigators

• Sponsor: Dr. med. Karsten Schenke
• Collaborators: Asklepios proresearch
• Investigators: Principal Investigator: Karsten Schenke, MD, Asklepios Klinik Bambek Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 7, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Radial artery occlusion; Anatomical snuffbox; Coronary catheterization; Radial access; Distal radial access; Radial artery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CORRECT Radial RCT 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No