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

Coronary Artery Disease Clinical Trial

— SEVEN-BOX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05006027
• Other study ID #: 9-2021-0031
• Status: Active, not recruiting
• Start date: August 16, 2021
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial artery access (DRA), also known as the snuffbox approach, 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 slender 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 wall sheath for radial artery, there is a lack of data regarding the safety and efficacy of a 7-Fr thin-wall sheath during the DRA.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 15, 2024
• Est. primary completion date: July 17, 2024
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients, = 20 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 wall 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous coronary intervention via the snuffbox approach
Percutaneous coronary intervention using a 7-Fr thin wall sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the snuffbox approach

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospital	Yongin	Gyeonggi-do
Korea, Republic of	Yongin Severance Hospital	Yongin

Sponsors (3)

Lead Sponsor	Collaborator
Yonsei University	Merit Medical Systems, Inc., Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 subclassi?ed 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
Primary	Success rate of PCI	Success rate of PCI using 7-Fr sheath via the snuffbox approach (%)	Through procedure completion, up to 1month
Secondary	Hemostasis duration	Hemostasis duration using 7-Fr sheath via the snuffbox approach (minute)	Through procedure completion, up to 24 hours
Secondary	Patency of proximal radial artery after hemostasis	Patency of proximal radial artery using 7-Fr sheath via the snuffbox approach by ultrasonography after hemostasis (%)	Through procedure completion, up to 24 hours
Secondary	Patency of distal radial artery after 1 month	Patency of distal radial artery using 7-Fr sheath via the snuffbox approach by ultrasonography after 1-month (%)	Time Frame: up to 1month
Secondary	If OCT is seen during intervention, check for radial artery complexity through OCT	If OCT is seen during intervention, check for radial artery complexity through OCT	Through procedure completion