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

NCT ID: NCT05006027

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2024-10-15

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.

Conditions

Coronary Artery Disease; Distal Radial Artery; Complex Intervention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Percutaneous coronary intervention using a 7-Fr thin-walled sheath 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

Percutaneous coronary intervention via the distal radial approach

Intervention Type: PROCEDURE

Percutaneous coronary intervention using a 7-Fr thin walled sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the distal radial approach

Interventions

Percutaneous coronary intervention via the distal radial approach

Percutaneous coronary intervention using a 7-Fr thin walled sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the distal radial approach

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yongcheol Kim

Director head of snuffbox center in Yongin Severance Hospital, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongcheol Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Yongin Severance Hopistal

Locations

Yongin Severance Hospital

Yongin, Gyeonggi-do, South Korea

Yongin Severance Hospital

Yŏngin, , South Korea

Countries

South Korea

References

Roh JW, Lee OH, Heo SJ, Kim Y, Im E, Cho DK. Feasibility of percutaneous coronary intervention using a 7-French thin-walled sheath via the distal radial access. Sci Rep. 2025 May 15;15(1):16961. doi: 10.1038/s41598-025-01149-1.

Reference Type: DERIVED

PMID: 40374669 (View on PubMed)

Other Identifiers

9-2021-0031

Identifier Type: -

Identifier Source: org_study_id