Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI

Completed

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT03943160

Run by

Abbott Medical Devices

People needed

50

Starts

2019-06-11

Expected to finish

2019-12-11

Last updated by the study team

2023-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Arizona Cardiovascular Research Center — Phoenix, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Cardiovascular Institute of the South - Lafayette General South West OBL — Lafayette, Louisiana, 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

Full record on ClinicalTrials.gov

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