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Not yet recruitingNCT06986889CONFINEUpdated May 23, 2025

Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access

An interventional study of Conventional radial artery access and Distal radial artery access in Coronary Arterial Disease (CAD), Distal Raidal Artery and Hand Functions, sponsored by Wujin People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Wujin People's Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
640
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Coronary Arterial Disease (CAD)
  • Distal Raidal Artery
  • Hand Functions

Keywords

  • Coronary arterial disease
  • Distal radial artery
  • Conventional radial artery
  • Hand dysfunction
03

In context

Lead sponsor

Wujin People's Hospital is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Indications for coronary diagnosis and intervention
  • Distal and conventional radial artery pulsation are palpable
  • Patient should be able to comply with the protocol

Exclusion criteria

Exclusion Criteria

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
640 participants (estimated)

Study arms

  • Experimental
    Distal radial artery access group

    Subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial artery access.

    Procedure: Distal radial artery access

  • Active comparator
    Conventional radial artery access group

    Subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial artery access.

    Procedure: Conventional radial artery access

Interventions

  • ProcedureConventional radial artery access

    Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization.

  • ProcedureDistal radial artery access

    Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization.

06

What researchers measure

Primary outcomes

  1. Hand Numbness

    Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure.

    Time frame: 24 hours after procedure

Secondary outcomes

  1. 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.

    Time frame: 24 hours and 1 month after procedure

  2. Thumb and Index Finger Pinch Test

    Thumb and forefinger lateral pinch strength (kg)

    Time frame: 24 hours before and after procedure, 1 month after procedure

  3. Hand Grip Test

    Hand grip strength test (kg)

    Time frame: 24 hours before and after procedure, 1 month after procedure

  4. Late-term Hand Numbness

    Number of participants with the hand numbness is evaluated through clinical consultations at 1 month after procedure.

    Time frame: 1 month after procedure

  5. 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.

    Time frame: 24 hours before procedure and 1 month after procedure

  6. Visual Analogue Scale (VAS) Scale (0-10)

    Pain assessment. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

    Time frame: 24 hours after procedure

  7. 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.

    Time frame: 24 hours and 1 month after procedure

  8. 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.

    Time frame: 24 hours and 1 month after procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

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 25819177 ↗
  • Sgueglia 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 35595672 ↗
  • Tehrani 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 38353242 ↗
  • Daralammouri 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 35911661 ↗
  • Chen 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 38331793 ↗
  • Babunashvili 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 39474765 ↗
  • Aminian 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 35595673 ↗
  • Al-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 38432334 ↗
  • Kozinski 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 38137677 ↗
  • Gupta 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06986889
Lead sponsor
Wujin People's Hospital
Responsible party
Sponsor
First posted
May 23, 2025
Start date
May 20, 2025 (estimated)
Primary completion
Mar 20, 2026 (estimated)
Completion
May 20, 2026 (estimated)
Last update
May 23, 2025

Study contacts

Feng Li, Ms
Contact
lifeng198boy@126.com
+86-0519-85579192
Gaojun Cai, MD
Contact
caigaojun@wjrmyy.cn
+86-0519-85579193
Gaojun Cai, MD
study chair · Cardiovascular department, Changzhou Wujin People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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