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Completed

NCT Number: NCT05006027

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital, Yongin, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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])

  2. Success rate of PCI

    Time frame: Through procedure completion, up to 1month

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

Secondary outcomes

  1. Hemostasis duration

    Time frame: Through procedure completion, up to 24 hours

    Hemostasis duration using 7-Fr thin-walled sheath via the distal radial approach (minute)

  2. Patency of proximal radial artery after hemostasis

    Time frame: 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 (%)

  3. Patency of distal radial artery after 1 month

    Time frame: 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 (%)

Other outcomes

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

    Time frame: Through procedure completion

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Merit Medical Systems, Inc.
  • Severance Hospital

Registry information

Official study title

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

Acronym: SEVEN-BOX

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2021
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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