Clinical trial NCT05006027: Feasibility of PCI Using a 7-Fr Thin-Walled Sheath Via the DRA
Official title: Feasibility of Percutaneous Coronary Intervention Using a 7-Fr Thin Walled Sheath Via the Distal Radial Approach: a Prospective Observational Study (SEVEN-BOX)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Distal Radial Artery
Complex Intervention
Keywords: distal radial artery
coronary artery disease
percutaneous coronary intervention
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Merit Medical Systems, Inc.
First posted: 2021-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Access site complication during hospitalization and within 1-month follow-up
timeFrame: Through procedure completion, up to 1month
measure: Success rate of PCI
timeFrame: Through procedure completion, up to 1month
Secondary outcomes:
measure: Hemostasis duration
timeFrame: Through procedure completion, up to 24 hours
measure: Patency of proximal radial artery after hemostasis
timeFrame: Through procedure completion, up to 24 hours
measure: Patency of distal radial artery after 1 month
timeFrame: Time Frame: up to 1month
Other outcomes:
measure: If intravascular imaging modalities (OCT/IVUS) are seen during intervention, check for conventional radial radial artery complications through OCT/IVUS
timeFrame: Through procedure completion
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
affiliation: Yongin Severance Hopistal
name: Yongcheol Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: