Coronary Arterial Disease (CAD)CONFINENCT06986889
Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access
A study testing Conventional radial artery access and Distal radial artery access in people with Coronary Arterial Disease (CAD) and Distal Raidal Artery, run by Wujin People's Hospital.
Trial summary
Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Arterial Disease (CAD), Distal Raidal Artery, Hand Functions
- What is being tested?
- Conventional radial artery access and Distal radial artery access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indications for coronary diagnosis and intervention
- Distal and conventional radial artery pulsation are palpable
- Patient should be able to comply with the protocol
Who cannot join
- Age < 18 years or ≥ 90 years
- Height ≥ 185 cm
- Acute STEMI
- Haemodynamic instability
- Contraindications to puncture at the puncture site (such as infection, scarring or indwelling needles)
- Enrollment in another study that competes or interferes with this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)
Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access
Read the detailed description
Coronary diagnosis and intervention via distal radial access has gradually become an alternative access to the conventional radial access because of its advantages of reducing radial artery occlusion (RAO), shortening compression time, and decreasing patient discomfort. However, as awareness of distal radial access has increased, some patients have been found to have symptoms such as abnormal hand sensation and inflexibility after the procedure.
The primary objective is to assess hand function after coronary diagnosis and intervention via distal vs conventional radial access at 24 hours and 1 month.
Hand sensory and motor dysfunction will be assessed by:
- Consultation and physical examination
- Hand grip test
- Hand pinch test (lateral pinch)
- Monofilament sensory test
- Quick DASH questionnaire
- High-frequent ultrasound The other endpoints include the success rate of puncture, the success rate of single-attempt puncture, time of puncture, procedural duration, duration of hemostasis, vascular complication, etc.
- Being tested
- Conventional radial artery access, Distal radial artery access
- Keywords
- Coronary arterial disease, Distal radial artery, Conventional radial artery, Hand dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional radial artery accessProcedure or surgery
Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization.
Distal radial artery accessProcedure or surgery
Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Distal radial artery access group | Experimental | Subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial artery access. Receives: Procedure: Distal radial artery access |
| Conventional radial artery access group | Active comparator | Subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial artery access. Receives: Procedure: Conventional radial artery access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Numbness
Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure.
Measured: 24 hours after procedure
Secondary outcomes (8)
Nerve Injury
Number of participants with the nerve injury is detected using high-frequent ultrasound or electromyography at 24 hours after procedure, and patients with nerve injury at 1 month follow-up will be recorded.
Measured: 24 hours and 1 month after procedure
Thumb and Index Finger Pinch Test
Thumb and forefinger lateral pinch strength (kg)
Measured: 24 hours before and after procedure, 1 month after procedure
Hand Grip Test
Hand grip strength test (kg)
Measured: 24 hours before and after procedure, 1 month after procedure
Late-term Hand Numbness
Number of participants with the hand numbness is evaluated through clinical consultations at 1 month after procedure.
Measured: 1 month after procedure
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100)
Upper extremity dysfunction questionnaire. Scores range from 0 to 100, with higher scores indicating greater dysfunction.
Measured: 24 hours before procedure and 1 month after procedure
Visual Analogue Scale (VAS) Scale (0-10)
Pain assessment. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: 24 hours after procedure
Hand Paresthesia
Number of participants with the hand paresthesia is assessed using monofilament test and/or two-point discrimination test at 24 hours after procedure, and patients with hand paresthesia at 1 month follow-up will be recorded.
Measured: 24 hours and 1 month after procedure
Hand Clumsiness
Number of participants with the hand clumsiness at 24 hours after procedure, and patients with hand clumsiness at 1 month follow-up will be recorded.
Measured: 24 hours and 1 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start20 May 2025 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, single-center clinical trial
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wujin People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaojun Cai, MD, Study chair, Cardiovascular department, Changzhou Wujin People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986889
- Sponsor's protocol ID
- 20250501
- Acronym
- CONFINE
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Leeuwen MA, van Mieghem NM, Lenzen MJ, Selles RW, Hoefkens MF, Zijlstra F, van Royen N. The effect of transradial coronary catheterization on upper limb function. JACC Cardiovasc Interv. 2015 Apr 20;8(4):515-23. doi: 10.1016/j.jcin.2014.10.025. Epub 2015 Mar 26.
PubMed 25819177Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17.
PubMed 35595672Tehrani BN, Sherwood MW, Damluji AA, Epps KC, Bakhshi H, Cilia L, Dassanayake I, Eltebaney M, Gattani R, Howard E, Kepplinger D, Ofosu-Somuah A, Batchelor WB. A Randomized Comparison of Radial Artery Intimal Hyperplasia Following Distal Versus Proximal Transradial Access for Coronary Angiography: PRESERVE RADIAL. J Am Heart Assoc. 2024 Feb 20;13(4):e031504. doi: 10.1161/JAHA.123.031504. Epub 2024 Feb 14.
PubMed 38353242Daralammouri Y, Nazzal Z, Mosleh YS, Abdulhaq HK, Khayyat ZY, Hamshary YE, Azamtta M, Ghanim A, Awwad F, Majadla S, Maree M, Hamaida J, Ismail Y. Distal Radial Artery Access in comparison to Forearm Radial Artery Access for Cardiac Catheterization: A Randomized Controlled Trial (DARFORA Trial). J Interv Cardiol. 2022 Jul 15;2022:7698583. doi: 10.1155/2022/7698583. eCollection 2022.
PubMed 35911661Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7.
PubMed 38331793Babunashvili AM, Pancholy S, Zulkarnaev AB, Kaledin AL, Kochanov IN, Korotkih AV, Kartashov DS, Babunashvili MA. Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study. Catheter Cardiovasc Interv. 2024 Dec;104(7):1396-1405. doi: 10.1002/ccd.31271. Epub 2024 Oct 30.
PubMed 39474765Aminian A, Sgueglia GA, Wiemer M, Kefer J, Gasparini GL, Ruzsa Z, van Leeuwen MAH, Ungureanu C, Leibundgut G, Vandeloo B, Kedev S, Bernat I, Ratib K, Iglesias JF, Al Hage E, Posteraro GA, Pascut D, Maes F, Regazzoli D, Kakonyi K, Meijers TA, Colletti G, Krivoshei L, Lochy S, Zafirovska B, Horak D, Nolan J, Degrauwe S, Tobita K, Saito S. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1191-1201. doi: 10.1016/j.jcin.2022.04.032. Epub 2022 May 17.
PubMed 35595673Al-Azizi K, Moubarak G, Dib C, Sayfo S, Szerlip M, Thomas S, Hale S, Zyl JV, Settele RM, Gonzalez OR, Ventura SJ, DiMaio JM, Mack MJ, Potluri S. Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 1-Year Outcomes. Am J Cardiol. 2024 Jun 1;220:102-110. doi: 10.1016/j.amjcard.2024.02.036. Epub 2024 Mar 2.
PubMed 38432334Kozinski L, Orzalkiewicz Z, Dabrowska-Kugacka A. Feasibility and Safety of the Routine Distal Transradial Approach in the Anatomical Snuffbox for Coronary Procedures: The ANTARES Randomized Trial. J Clin Med. 2023 Dec 11;12(24):7608. doi: 10.3390/jcm12247608.
PubMed 38137677Gupta M, Kumar V, Rahman MW, Srivastava S, Pandey U, Sinha SK. Comparison Between Distal Trans-radial Access and Conventional Trans-radial Access for Coronary Angiography. Cureus. 2023 Sep 12;15(9):e45081. doi: 10.7759/cureus.45081. eCollection 2023 Sep.
PubMed 37842393
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)
- ClinicalTrials.gov ID
- NCT06986889
- Acronym / sponsor ID
- CONFINE / 20250501
- Keywords
- Coronary arterial disease, Distal radial artery, Conventional radial artery, Hand dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Wujin People's HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 23 May 2025 (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.
Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access
Detailed description
Coronary diagnosis and intervention via distal radial access has gradually become an alternative access to the conventional radial access because of its advantages of reducing radial artery occlusion (RAO), shortening compression time, and decreasing patient discomfort. However, as awareness of distal radial access has increased, some patients have been found to have symptoms such as abnormal hand sensation and inflexibility after the procedure.
The primary objective is to assess hand function after coronary diagnosis and intervention via distal vs conventional radial access at 24 hours and 1 month.
Hand sensory and motor dysfunction will be assessed by:
- Consultation and physical examination
- Hand grip test
- Hand pinch test (lateral pinch)
- Monofilament sensory test
- Quick DASH questionnaire
- High-frequent ultrasound The other endpoints include the success rate of puncture, the success rate of single-attempt puncture, time of puncture, procedural duration, duration of hemostasis, vascular complication, etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, single-center clinical trial
| Arm | Type | Receives |
|---|---|---|
| Distal radial artery access group | Experimental | Procedure: Distal radial artery accessSubjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial artery access. |
| Conventional radial artery access group | Active comparator | Procedure: Conventional radial artery accessSubjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial artery access. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indications for coronary diagnosis and intervention
- Distal and conventional radial artery pulsation are palpable
- Patient should be able to comply with the protocol
Key exclusion criteria (6 listed)
- Age < 18 years or ≥ 90 years
- Height ≥ 185 cm
- Acute STEMI
- Haemodynamic instability
- Contraindications to puncture at the puncture site (such as infection, scarring or indwelling needles)
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 |
|---|---|---|
| Conventional radial artery accessHalf of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization. | Procedure or surgery | Conventional radial artery access group |
| Distal radial artery accessHalf of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization. | Procedure or surgery | Distal radial artery access group |
Primary outcome
Hand Numbness
Time frame: 24 hours after procedure
Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure.
8 secondary outcomes
Nerve Injury
Time frame: 24 hours and 1 month after procedure
Thumb and Index Finger Pinch Test
Time frame: 24 hours before and after procedure, 1 month after procedure
Hand Grip Test
Time frame: 24 hours before and after procedure, 1 month after procedure
Late-term Hand Numbness
Time frame: 1 month after procedure
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100)
Time frame: 24 hours before procedure and 1 month after procedure
Visual Analogue Scale (VAS) Scale (0-10)
Time frame: 24 hours after procedure
Hand Paresthesia
Time frame: 24 hours and 1 month after procedure
Hand Clumsiness
Time frame: 24 hours and 1 month after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Results publication: PubMed 25819177van Leeuwen MA, van Mieghem NM, Lenzen MJ, Selles RW, Hoefkens MF, Zijlstra F, van Royen N. The effect of transradial coronary catheterization on upper limb function. JACC Cardiovasc Interv. 2015 Apr 20;8(4):515-23. doi: 10.1016/j.jcin.2014.10.025. Epub 2015 Mar 26.
- Results publication: PubMed 35595672Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17.
- Results publication: PubMed 38353242Tehrani BN, Sherwood MW, Damluji AA, Epps KC, Bakhshi H, Cilia L, Dassanayake I, Eltebaney M, Gattani R, Howard E, Kepplinger D, Ofosu-Somuah A, Batchelor WB. A Randomized Comparison of Radial Artery Intimal Hyperplasia Following Distal Versus Proximal Transradial Access for Coronary Angiography: PRESERVE RADIAL. J Am Heart Assoc. 2024 Feb 20;13(4):e031504. doi: 10.1161/JAHA.123.031504. Epub 2024 Feb 14.
- Results publication: PubMed 35911661Daralammouri Y, Nazzal Z, Mosleh YS, Abdulhaq HK, Khayyat ZY, Hamshary YE, Azamtta M, Ghanim A, Awwad F, Majadla S, Maree M, Hamaida J, Ismail Y. Distal Radial Artery Access in comparison to Forearm Radial Artery Access for Cardiac Catheterization: A Randomized Controlled Trial (DARFORA Trial). J Interv Cardiol. 2022 Jul 15;2022:7698583. doi: 10.1155/2022/7698583. eCollection 2022.
- Results publication: PubMed 38331793Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7.
- Results publication: PubMed 39474765Babunashvili AM, Pancholy S, Zulkarnaev AB, Kaledin AL, Kochanov IN, Korotkih AV, Kartashov DS, Babunashvili MA. Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study. Catheter Cardiovasc Interv. 2024 Dec;104(7):1396-1405. doi: 10.1002/ccd.31271. Epub 2024 Oct 30.
- Results publication: PubMed 35595673Aminian A, Sgueglia GA, Wiemer M, Kefer J, Gasparini GL, Ruzsa Z, van Leeuwen MAH, Ungureanu C, Leibundgut G, Vandeloo B, Kedev S, Bernat I, Ratib K, Iglesias JF, Al Hage E, Posteraro GA, Pascut D, Maes F, Regazzoli D, Kakonyi K, Meijers TA, Colletti G, Krivoshei L, Lochy S, Zafirovska B, Horak D, Nolan J, Degrauwe S, Tobita K, Saito S. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1191-1201. doi: 10.1016/j.jcin.2022.04.032. Epub 2022 May 17.
- Results publication: PubMed 38432334Al-Azizi K, Moubarak G, Dib C, Sayfo S, Szerlip M, Thomas S, Hale S, Zyl JV, Settele RM, Gonzalez OR, Ventura SJ, DiMaio JM, Mack MJ, Potluri S. Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 1-Year Outcomes. Am J Cardiol. 2024 Jun 1;220:102-110. doi: 10.1016/j.amjcard.2024.02.036. Epub 2024 Mar 2.
- Results publication: PubMed 38137677Kozinski L, Orzalkiewicz Z, Dabrowska-Kugacka A. Feasibility and Safety of the Routine Distal Transradial Approach in the Anatomical Snuffbox for Coronary Procedures: The ANTARES Randomized Trial. J Clin Med. 2023 Dec 11;12(24):7608. doi: 10.3390/jcm12247608.
- Results publication: PubMed 37842393Gupta M, Kumar V, Rahman MW, Srivastava S, Pandey U, Sinha SK. Comparison Between Distal Trans-radial Access and Conventional Trans-radial Access for Coronary Angiography. Cureus. 2023 Sep 12;15(9):e45081. doi: 10.7759/cureus.45081. eCollection 2023 Sep.
- 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.
Gaojun Cai, MD study chair
Cardiovascular department, Changzhou Wujin People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Conventional radial artery access and Distal radial artery access in people with Coronary Arterial Disease (CAD) and Distal Raidal Artery, run by Wujin People's Hospital.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Li, Ms (+86-0519-85579192, lifeng198boy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Numbness (time frame: 24 hours after procedure). 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 NCT06986889, which also lists 10 linked publications.
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 23 May 2025.