Feasibility of PCI Using a 7-Fr Thin-Walled Sheath Via the DRA (SEVEN-BOX)

Feasibility of Percutaneous Coronary Intervention Using a 7-Fr Thin Walled Sheath Via the Distal Radial Approach: a Prospective Observational Study (SEVEN-BOX)

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Distal Radial Artery; Complex Intervention
• Intervention / Treatment: Procedure: Percutaneous coronary intervention 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• South Korea
  • Yŏngin, South Korea
    • Yongin Severance Hospital
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, South Korea, 16995
      • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
If intravascular imaging modalities (OCT/IVUS) are seen during intervention, check for conventional radial radial artery complications through OCT/IVUS	If intravascular imaging modalities (OCT/IVUS) are seen during intervention, check for conventional radial radial artery complications through OCT/IVUS	Through procedure completion

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Severance Hospital; Merit Medical Systems, Inc.
• Investigators: Principal Investigator: Yongcheol Kim, MD, Yongin Severance Hopistal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): July 17, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: August 8, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery disease; distal radial artery
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 9-2021-0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes