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Not yet recruiting NCT06986889

Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access

No phase Interventional Coronary Arterial Disease (CAD) Distal Raidal Artery Hand Functions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional radial artery access, Distal radial artery access.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Distal Raidal Artery, Hand Functions. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)

Overview

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.

Interventions

  • Procedure Conventional 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.
  • Procedure Distal 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.

Primary outcome measures

  • Hand Numbness [Time frame: 24 hours after procedure]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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 Angiogr PMID 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. PMID 38432334

Identifiers

NCT: NCT06986889 · 20250501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗