Feasibility of PCI Using a 7-Fr Thin-Walled Sheath Via the DRA

Active, not recruiting

• Conditions: Coronary Artery Disease; Distal Radial Artery; Complex Intervention
• Interventions: Procedure: Percutaneous coronary intervention via the distal radial approach

• Registration Number: NCT05006027
• Lead Sponsor: Yonsei University

Brief Summary

To evaluate the safety and effectiveness of percutaneous coronary intervention using a 7-French(Fr) thin-walled sheath via the distal radial approach

Detailed Description

Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial artery access (DRA) have shown several advantages owing to fewer complications, such as radial artery occlusion, pseudoaneurysms, and arteriovenous(AV) fistulas, and short hemostasis duration than the proximal radial access (PRA). However, despite the potential advantages of the DRA, there are still many cardiologists who prefer the femoral approach for complex PCI including left main disease, bifurcation lesions, heavily calcified lesions, which need a strong backup and using several devices. The radial artery and the distal radial artery have a smaller diameter than the femoral artery, and interventional cardiologists are usually performed using the 6-Fr sheath. The previously developed 7-Fr sheath has a higher risk of vascular occlusion when use in a radial artery due to larger diameter compared to radial artery in 30% to 60% of patients. However, with the recent development of various technologies, the outer diameter of the sheath is gradually becoming thinner and recently a 7-Fr thin-walled sheath which does not differ significantly from the outer diameter of the 6-Fr sheath used in the previously PRA demonstrated that feasibility and safety for radial artery intervention. Despite the feasibility and potential benefits of the DRA and 7-Fr thin-walled sheath for radial artery, there is a lack of data regarding the safety and efficacy of a 7-Fr thin-walled sheath during the DRA.

Study Timeline

• Study First Submitted: 2021-08-08
• Study First Submitted QC: 2021-08-12
• Study Start: 2021-08-16
• Study First Posted: 2021-08-16
• Primary Completion: 2024-07-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients, ≥ 19 years of age, who were diagnosed with ischemic heart disease requiring percutaneous coronary intervention (PCI)
• Patients who are palpable distal radial artery
• The decision to participate voluntarily in this study and the written consent of the patient
• Patients who planned to perform PCI using a 7-Fr thin-walled sheath

Exclusion Criteria

• Patients who are not palpable distal radial artery
• Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study
• Pregnancy
• Patients who are not appropriate for this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous coronary intervention using a 7-Fr thin-walled sheath via the distal radial approach	Percutaneous coronary intervention via the distal radial approach	patients with coronary artery disease who planned to perform PCI using 7-Fr thin-walled sheath via the distal radial approach

Primary Outcome Measures

Name	Time	Method
Access site complication during hospitalization and within 1-month follow-up	Through procedure completion, up to 1month	bleeding(defined by BARC criteria), hematoma (using modified EASY\[Early Discharge After Transradial Stenting of Coronary Arteries Study\] classification: A) Grade Ia hematoma was subclassified into 4 grades from the puncture site \[Grade 1, \<2cm; Grade2, 2-5cm; Grade3,\>5cm; and grade 4, hand swelling\], B) Grade Ib, wrist \< 5cm, C) Grade II, wrist \< 10cm, D) Grade III, forearm, E) Grade IV, upper arm), numbness, AV fistula, Pseudoaneurysm, and conventional and distal radial artery occlusion (assessed by manual palpation or ultrasonography\[prefer\])
Success rate of PCI	Through procedure completion, up to 1month	Success rate of PCI using 7-Fr sheath via the distal radial approach (%)

Secondary Outcome Measures

Name	Time	Method
Patency of distal radial artery after 1 month	Time Frame: up to 1month	Patency of distal radial artery using 7-Fr thin-walled sheath via the snuffbox approach by ultrasonography after 1-month (%)
Hemostasis duration	Through procedure completion, up to 24 hours	Hemostasis duration using 7-Fr thin-walled sheath via the distal radial approach (minute)
Patency of proximal radial artery after hemostasis	Through procedure completion, up to 24 hours	Patency of proximal radial artery using 7-Fr thin-walled sheath via the distal radial approach by ultrasonography after hemostasis (%)

Trial Locations

Locations (1)

Yongin Severance Hospital; 🇰🇷 Yongin, Korea, Republic of