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

Primary Purpose

Coronary Angiography, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Use of radial artery for access for a coronary angiography or intervention
Sponsored by
Dr. med. Karsten Schenke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Angiography focused on measuring Anatomical snuffbox, Percutaneous coronary intervention, Radial access, Distal radial access, Radial artery occlusion, Coronary catheterization, Radial artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Landkreis Erding
  • Sana Kliniken Düsseldorf GmbH
  • Asklepios Klinik BarmbekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Forearm radial access

Distal radial access

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 7, 2019
Last Updated
January 31, 2023
Sponsor
Dr. med. Karsten Schenke
Collaborators
Asklepios proresearch
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1. Study Identification

Unique Protocol Identification Number
NCT04194606
Brief Title
CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess
Acronym
CORRECT Radial
Official Title
CORRECT RADIAL RCT: CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess - a Randomized Trial of Different Radial Puncture Sites
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. med. Karsten Schenke
Collaborators
Asklepios proresearch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Angiography, Coronary Artery Disease
Keywords
Anatomical snuffbox, Percutaneous coronary intervention, Radial access, Distal radial access, Radial artery occlusion, Coronary catheterization, Radial artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicenter, open Label randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Forearm radial access
Arm Type
Active Comparator
Arm Description
Patients who undergo coronary angiography or intervention by forearm radial artery access
Arm Title
Distal radial access
Arm Type
Experimental
Arm Description
Patients who undergo coronary angiography or intervention by accessing the distal radial artery in the area of the anatomical snuff-box
Intervention Type
Procedure
Intervention Name(s)
Use of radial artery for access for a coronary angiography or intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower rate of forearm radial artery occlusion (RAO)
Description
Use of color doppler ultrasound to assess the patency of the radial artery used in the index procedure.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Puncture success rate of the randomized puncture site
Description
Comparison of the rate of successful Insertion of the sheath in each group
Time Frame
During the procedure
Title
Access cross over rate
Description
Comparison of the rate of access site cross over in each group to complete the planned procedure
Time Frame
During the procedure
Title
Duration of puncture
Description
Exact measurement of the duration of the puncture in seconds
Time Frame
During the procedure
Title
Hematoma, bleeding and other complications
Description
Registration of complications associated with the procedure, hematoma size, bleeding according to the BARC Score
Time Frame
48 hours
Title
Use of standard questionaire to assess pain
Description
Visual analog scale is used to assess pain
Time Frame
30 days
Title
Incidence of vasospasm
Description
The incidence of vasospasm that necessitates additional medication or Forces Access site cross over is registered
Time Frame
during the procedure
Title
Use of standard questionaire to assess Hand function
Description
QuickDASH questionaire is used to assess Hand function
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karsten Schenke, MD
Phone
+49401818824811
Email
k.schenke@asklepios.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gerian Grönefeld, MD
Phone
+49401818824811
Email
g.groenefeld@asklepios.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Schenke, MD
Organizational Affiliation
Asklepios Klinik Bambek Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Landkreis Erding
City
Erding
State/Province
Bavaria
ZIP/Postal Code
85435
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nader Joghetaei, MD
Phone
+49 8122 59-1760
Email
nader.joghetaei@klinikum-erding.de
First Name & Middle Initial & Last Name & Degree
Nader Joghetaei, MD
Facility Name
Sana Kliniken Düsseldorf GmbH
City
Düsseldorf
State/Province
NRW
ZIP/Postal Code
40953
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rostyslav Prog, MD
Phone
+49 211 997 24656
Email
rostyslav.prog@sana.de
First Name & Middle Initial & Last Name & Degree
Rostyslav Prog, MD
Facility Name
Asklepios Klinik Barmbek
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Schenke, MD
Phone
+49401818828381
Email
k.schenke@asklepios.com
First Name & Middle Initial & Last Name & Degree
Achim Viertel, MD
Phone
+49401818826457
Email
a.viertel@asklepios.com
First Name & Middle Initial & Last Name & Degree
Gerian Groenefeld, MD
First Name & Middle Initial & Last Name & Degree
Achim Viertel, MD
First Name & Middle Initial & Last Name & Degree
Karsten Schenke, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess

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