Complex Intervention, Coronary Artery Disease, Distal Radial Artery
Conditions
Keywords
distal radial artery, coronary artery disease, percutaneous coronary intervention
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.
Interventions
PROCEDUREPercutaneous 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
Sponsors
Severance Hospital
Merit Medical Systems, Inc.
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access site complication during hospitalization and within 1-month follow-up | 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\[prefer\]) |
| Success rate of PCI | Through procedure completion, up to 1month | Success rate of PCI using 7-Fr sheath via the distal radial approach (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis duration | Through procedure completion, up to 24 hours | Hemostasis duration using 7-Fr thin-walled sheath via the distal radial approach (minute) |
| Patency of proximal radial artery after hemostasis | 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 (%) |
| Patency of distal radial artery after 1 month | 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
| Measure | Time frame | Description |
|---|---|---|
| If intravascular imaging modalities (OCT/IVUS) are seen during intervention, check for conventional radial radial artery complications through OCT/IVUS | Through procedure completion | If intravascular imaging modalities (OCT/IVUS) are seen during intervention, check for conventional radial radial artery complications through OCT/IVUS |
Countries
South Korea
Outcome results
None listed