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

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Yonsei University

Status

Active, not recruiting

Conditions

Distal Radial Artery
Coronary Artery Disease
Complex Intervention

Treatments

Procedure: Percutaneous coronary intervention via the distal radial approach

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05006027
9-2021-0031

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

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

Trial contacts and locations

2

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Central trial contact

Ji Woong Roh, MD, PhD; Yongcheol Kim, MD

Data sourced from clinicaltrials.gov

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