Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access

NCT06986889 | Not Yet Recruiting

• 1 other identifier: 20250501
• Study Type: interventional
• Target: 640
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access

Conditions

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

Keywords

Coronary arterial disease; Distal radial artery; Conventional radial artery; Hand dysfunction

Outcome Measures

Primary Outcomes (1)

• Hand Numbness

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

  24 hours after procedure

Secondary Outcomes (8)

• Nerve Injury

  24 hours and 1 month after procedure

• Thumb and Index Finger Pinch Test

  24 hours before and after procedure, 1 month after procedure

• Hand Grip Test

  24 hours before and after procedure, 1 month after procedure

• Late-term Hand Numbness

  1 month after procedure

• Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100)

  24 hours before procedure and 1 month after procedure

Study Arms (2)

Distal radial artery access group

EXPERIMENTAL

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

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.

Procedure: Conventional radial artery access

Interventions

Conventional radial artery access PROCEDURE

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

Conventional radial artery access group

Distal radial artery access PROCEDURE

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

Distal radial artery access group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wujin People's Hospital: lead

Related Publications (10)

• 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.

  PMID: 25819177 BACKGROUND

• 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.

  PMID: 35595672 BACKGROUND

• 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.

  PMID: 38353242 BACKGROUND

• 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.

  PMID: 35911661 BACKGROUND

• 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.

  PMID: 38331793 BACKGROUND

• 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.

  PMID: 39474765 BACKGROUND

• 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.

  PMID: 35595673 BACKGROUND

• 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.

  PMID: 38432334 BACKGROUND

• 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.

  PMID: 38137677 BACKGROUND

• 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.

  PMID: 37842393 BACKGROUND

Study Officials

• Gaojun Cai, MD

  Cardiovascular department, Changzhou Wujin People's Hospital

  STUDY CHAIR

Central Study Contacts

Feng Li, Ms

CONTACT

+86-0519-85579192; lifeng198boy@126.com

Gaojun Cai, MD

CONTACT

+86-0519-85579193; caigaojun@wjrmyy.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, single-center clinical trial

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: May 20, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share