Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT03943160
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
- Detailed Description
The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Subject is ≥ 18 years
- Subject is willing and able to sign the IRB-approved informed consent form (ICF)
- Subject presents with a Rutherford Classification of 2 to 5
- Subject has a positive Allen's Test
- Subject to undergo peripheral angiography and/or PVI via TRA approach per physician discretion
Index Procedure Inclusion Criteria:
- Physician obtains successful radial artery access (Note: snuffbox access is allowed)
- Target lesion appropriate (i.e. location/morphology) for OA treatment via TRA within target area
- OAS use attempted (defined as ViperWire introduced into the body)
- Subject has no palpable radial artery on the planned access arm
- Subject has a previous failed radial access attempt on planned access arm
- Subject has a dialysis fistula on planned access arm
- Subject has a known subclavian stenosis or occlusion
- Subject has a previous subclavian stent or previous subclavian intervention
- Subject has a shunt in the radial artery on the planned access arm
- Subject has evidence of osteomyelitis
- Subject is currently participating in an investigational drug or device study
- Subject is pregnant within the study period
Index Procedure Exclusion Criteria
-
Physician unable to obtain radial artery access
-
Physician determines TRA is not acceptable due to patient anatomy, lesion characteristics, and/or disease severity
-
OAS use not attempted (defined as ViperWire introduced into the body)
Prior to insertion of ViperWire:
-
Femoral access is obtained
-
Unsuccessful peripheral intervention
-
A reportable adverse event has occurred
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedural Success: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure) Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm.
- Secondary Outcome Measures
Name Time Method Treatment Success: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours Treatment success is defined as \<50% residual stenosis post-procedure and without significant angiographic complications without stent placement, or \<30% residual stenosis post-procedure and without significant angiographic complications with stent placement.
Trial Locations
- Locations (6)
Cardiovascular Institute of the South - Lafayette General South West OBL
🇺🇸Lafayette, Louisiana, United States
Arizona Cardiovascular Research Center
🇺🇸Phoenix, Arizona, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Mercy Hospital, Springfield
🇺🇸Chesterfield, Missouri, United States
Columbia University Medical Center/New York Presbyterian
🇺🇸New York, New York, United States
Sorin Medical, P.C.
🇺🇸New York, New York, United States