CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess

Coronary Artery Disease Clinical Trial

— CORRECT Radial  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194606
• Other study ID #: CORRECT Radial RCT 2019
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Asklepios Kliniken Hamburg GmbH
• Contact: Karsten Schenke, MD
• Phone: +49401818824811
• Email: k.schenke[@]asklepios.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Angiography
• Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
Germany	Sana Kliniken Düsseldorf GmbH	Düsseldorf	NRW
Germany	Klinikum Landkreis Erding	Erding	Bavaria
Germany	Asklepios Klinik Barmbek	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Dr. med. Karsten Schenke	Asklepios proresearch

Country where clinical trial is conducted

Germany, 

Outcome

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