Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)

NCT ID: NCT05253820

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

801 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-08-01

Brief Summary

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Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach

Detailed Description

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Coronary diagnosis and intervention via distal radial artery is prevalent worldwide. This study aims to explore the long-term radial artery occlusion after coronary diagnosis and intervention via distal radial artery at 3 months after procedure using portable high-frequent ultrasound. The secondary endpoints include the success rate of puncture, time of puncture, duration of hemostasis, radial artery trauma, etc.

Conditions

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Coronary Artery Disease Distal Radial Artery Radial Artery Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center parallel randomized controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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distal radial approach group

subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach

Group Type EXPERIMENTAL

distal radial approach

Intervention Type PROCEDURE

coronary diagnosis and intervention via distal vs conventional radial approach

conventional radial access group

subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach

Group Type ACTIVE_COMPARATOR

conventional radial access

Intervention Type PROCEDURE

conventional radial access

Interventions

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distal radial approach

coronary diagnosis and intervention via distal vs conventional radial approach

Intervention Type PROCEDURE

conventional radial access

conventional radial access

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years;
* Palpable unilateral distal radial and radial artery

Exclusion Criteria

* Age ≥ 90years;
* Height≥ 185cm;
* Cardiogenic shock;
* Contraindications to puncture at the puncture site;
* Inability to obtain written informed consent
* Previous right radial or distal artery intervention
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wujin People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gaojun Cai, MD

Role: STUDY_CHAIR

Cardiovascular department, Changzhou Wujin People's Hospital

Locations

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Changzhou Wujin People's Hospital

Changzhou, Jiangsu, China

Site Status

Countries

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China

References

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Gupta A, Agstam S. Radial Artery Pseudoaneurysm Following Percutaneous Coronary Intervention. J Invasive Cardiol. 2021 May;33(5):E406. doi: 10.25270/jic/20.00272.

Reference Type RESULT
PMID: 33932290 (View on PubMed)

Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002686. doi: 10.1161/JAHA.115.002686.

Reference Type RESULT
PMID: 26811162 (View on PubMed)

Tehrani DM, Seto AH. Heparin, compression, and radial artery occlusion: Less is more. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):1377-1378. doi: 10.1002/ccd.29764. No abstract available.

Reference Type RESULT
PMID: 34107564 (View on PubMed)

Hadjivassiliou A, Kiemeneij F, Nathan S, Klass D. Ultrasound-guided access to the distal radial artery at the anatomical snuffbox for catheter-based vascular interventions: a technical guide. EuroIntervention. 2021 Mar 19;16(16):1342-1348. doi: 10.4244/EIJ-D-19-00555.

Reference Type RESULT
PMID: 31380781 (View on PubMed)

Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.

Reference Type RESULT
PMID: 28506941 (View on PubMed)

Soydan E, Akin M. Applicability of left distal radial artery access site in ST-segment elevation myocardial infarction; A comparative evaluation with the conventional transfemoral approach. J Vasc Access. 2022 Jan;23(1):81-87. doi: 10.1177/1129729820983138. Epub 2020 Dec 21.

Reference Type RESULT
PMID: 33349158 (View on PubMed)

Colletti G, Auslender J, De Meester A, Aminian A, Kayaert P, Ungureanu C. Feasibility and Safety of Performing Complex Coronary Interventions by Distal Radial Artery Using the Railway Sheathless Vascular System. J Invasive Cardiol. 2020 Dec;32(12):459-462. doi: 10.25270/jic/20.00201. Epub 2020 Oct 10.

Reference Type RESULT
PMID: 33035178 (View on PubMed)

Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.

Reference Type RESULT
PMID: 33380922 (View on PubMed)

Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.

Reference Type RESULT
PMID: 34922888 (View on PubMed)

Mhanna M, Beran A, Nazir S, Al-Abdouh A, Barbarawi M, Sajdeya O, Ayesh H, Nesheiwat Z, Malhas SE, Eltahawy EA. Outcomes of distal versus conventional transradial access for coronary angiography and intervention: An updated systematic review and meta-analysis. Int J Cardiol. 2021 Dec 1;344:47-53. doi: 10.1016/j.ijcard.2021.10.003. Epub 2021 Oct 6.

Reference Type RESULT
PMID: 34626744 (View on PubMed)

Eid-Lidt G, Rivera Rodriguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada Lopez KE, Gaspar J. Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial. JACC Cardiovasc Interv. 2021 Feb 22;14(4):378-385. doi: 10.1016/j.jcin.2020.10.013.

Reference Type RESULT
PMID: 33602433 (View on PubMed)

Hamilton GW, Farouque O. Could Distal Radial Artery Access do More Than "Just" Reduce Rates of Radial Artery Occlusion? JACC Cardiovasc Interv. 2021 May 10;14(9):1042-1043. doi: 10.1016/j.jcin.2021.03.055. No abstract available.

Reference Type RESULT
PMID: 33958163 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38331793 (View on PubMed)

Other Identifiers

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20220130

Identifier Type: -

Identifier Source: org_study_id

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