Coronary AngiographyCORRECT RadialNCT04194606
CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess
A study testing Use of radial artery for access for a coronary angiography or intervention in people with Coronary Angiography and Coronary Artery Disease, run by Dr. med. Karsten Schenke at 3 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Coronary Artery Disease
- What is being tested?
- Use of radial artery for access for a coronary angiography or intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesGermany
- Study dates
- 14 Jan 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Not yet recruiting
Sana Kliniken Düsseldorf GmbH
Düsseldorf, North Rhine-Westphalia, 40953
Rostyslav Prog, MD, +49 211 997 24656, rostyslav.prog@sana.de
Rostyslav Prog, MD
- Not yet recruiting
Klinikum Landkreis Erding
Erding, Bavaria, 85435
Nader Joghetaei, MD, +49 8122 59-1760, nader.joghetaei@klinikum-erding.de
Nader Joghetaei, MD
- Recruiting
Asklepios Klinik Barmbek
Hamburg, 22291
Karsten Schenke, MD, +49401818828381, k.schenke@asklepios.com
Achim Viertel, MD, +49401818826457, a.viertel@asklepios.com
About this study
Official title: 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.
Read the 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
- Being tested
- Use of radial artery for access for a coronary angiography or intervention
- Keywords
- Anatomical snuffbox, Percutaneous coronary intervention, Radial access, Distal radial access, Radial artery occlusion, Coronary catheterization, Radial artery
- Medical subject headings
- Coronary Artery Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of radial artery for access for a coronary angiography or interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Forearm radial access | Active comparator | Patients who undergo coronary angiography or intervention by forearm radial artery access Receives: 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 Receives: Procedure: Use of radial artery for access for a coronary angiography or intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (7)
Puncture success rate of the randomized puncture site
Comparison of the rate of successful Insertion of the sheath in each group
Measured: During the procedure
Access cross over rate
Comparison of the rate of access site cross over in each group to complete the planned procedure
Measured: During the procedure
Duration of puncture
Exact measurement of the duration of the puncture in seconds
Measured: During the procedure
Hematoma, bleeding and other complications
Registration of complications associated with the procedure, hematoma size, bleeding according to the BARC Score
Measured: 48 hours
Use of standard questionaire to assess pain
Visual analog scale is used to assess pain
Measured: 30 days
Incidence of vasospasm
The incidence of vasospasm that necessitates additional medication or Forces Access site cross over is registered
Measured: during the procedure
Use of standard questionaire to assess Hand function
QuickDASH questionaire is used to assess Hand function
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start14 Jan 2020
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, open Label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. med. Karsten Schenke
- Sponsor type
- University, hospital or other
- Collaborators
- Asklepios proresearch
- Responsible party
- Sponsor-investigator, Dr. med. Karsten Schenke, Asklepios Kliniken Hamburg GmbH
- Investigators
- Karsten Schenke, MD, Principal investigator, Asklepios Klinik Bambek Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194606
- Sponsor's protocol ID
- CORRECT Radial RCT 2019
- Acronym
- CORRECT Radial
- Status last verified
- Jan 2023
- First submitted
- 7 Dec 2019
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41284047
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORRECT RADIAL RCT: CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess - a Randomized Trial of Different Radial Puncture Sites
- ClinicalTrials.gov ID
- NCT04194606
- Acronym / sponsor ID
- CORRECT Radial / CORRECT Radial RCT 2019
- Conditions
- Coronary Angiography, Coronary Artery Disease
- Keywords
- Anatomical snuffbox, Percutaneous coronary intervention, Radial access, Distal radial access, Radial artery occlusion, Coronary catheterization, Radial artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dr. med. Karsten SchenkeUniversity, hospital or other
- Collaborators
- Asklepios proresearch
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, open Label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Forearm radial access | Active comparator | Procedure: Use of radial artery for access for a coronary angiography or interventionPatients who undergo coronary angiography or intervention by forearm radial artery access |
| Distal radial access | Experimental | Procedure: Use of radial artery for access for a coronary angiography or interventionPatients who undergo coronary angiography or intervention by accessing the distal radial artery in the area of the anatomical snuff-box |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of radial artery for access for a coronary angiography or interventionAfter 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. | Procedure or surgery | Distal radial access, Forearm radial access |
Primary outcome
Lower rate of forearm radial artery occlusion (RAO)
Time frame: 30 days
Use of color doppler ultrasound to assess the patency of the radial artery used in the index procedure.
7 secondary outcomes
Puncture success rate of the randomized puncture site
Time frame: During the procedure
Access cross over rate
Time frame: During the procedure
Duration of puncture
Time frame: During the procedure
Hematoma, bleeding and other complications
Time frame: 48 hours
Use of standard questionaire to assess pain
Time frame: 30 days
Incidence of vasospasm
Time frame: during the procedure
Use of standard questionaire to assess Hand function
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 41284047Schenke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karsten Schenke, MD principal investigator
Asklepios Klinik Bambek Hamburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of radial artery for access for a coronary angiography or intervention in people with Coronary Angiography and Coronary Artery Disease, run by Dr. med. Karsten Schenke at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karsten Schenke, MD (+49401818824811, k.schenke@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower rate of forearm radial artery occlusion (RAO) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.