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

NCT05006027 | Completed

• 1 other identifier: 9-2021-0031
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Coronary Artery Disease; Distal Radial Artery; Complex Intervention

Keywords

distal radial artery; coronary artery disease; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• Access site complication during hospitalization and within 1-month follow-up

  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\[prefer\])

  Through procedure completion, up to 1month

• Success rate of PCI

  Success rate of PCI using 7-Fr sheath via the distal radial approach (%)

  Through procedure completion, up to 1month

Secondary Outcomes (3)

• Hemostasis duration

  Through procedure completion, up to 24 hours

• Patency of proximal radial artery after hemostasis

  Through procedure completion, up to 24 hours

• Patency of distal radial artery after 1 month

  Time Frame: up to 1month

Other Outcomes (1)

• If intravascular imaging modalities (OCT/IVUS) are seen during intervention, check for conventional radial radial artery complications through OCT/IVUS

  Through procedure completion

Study Arms (1)

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

Procedure: Percutaneous coronary intervention via the distal radial approach

Interventions

Percutaneous coronary intervention via the distal radial approach PROCEDURE

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

Percutaneous coronary intervention using a 7-Fr thin-walled sheath via the distal radial approach

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with coronary artery disease who planned to perform PCI using a 7-Fr thin-walled sheath will be recruited

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• Severance Hospital: collaborator
• Merit Medical Systems, Inc.: collaborator

Study Sites (2)

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

Location

Yongin Severance Hospital

Yŏngin, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40374669 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yongcheol Kim, MD

  Yongin Severance Hopistal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director head of snuffbox center in Yongin Severance Hospital, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 16, 2021
• Study Start: August 16, 2021
• Primary Completion: July 17, 2024
• Study Completion: October 15, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)