Clinical trial NCT03943160: Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
Official title: Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 years
2. Subject is willing and able to sign the IRB-approved informed consent form (ICF)
3. Subject presents with a Rutherford Classification of 2 to 5
4. Subject has a positive Allen's Test
5. Subject to undergo peripheral angiography and/or PVI via TRA approach per physician discretion

Index Procedure Inclusion Criteria:

1. Physician obtains successful radial artery access (Note: snuffbox access is allowed)
2. Target lesion appropriate (i.e. location/morphology) for OA treatment via TRA within target area
3. OAS use attempted (defined as ViperWire introduced into the body)

Exclusion Criteria:

1. Subject has no palpable radial artery on the planned access arm
2. Subject has a previous failed radial access attempt on planned access arm
3. Subject has a dialysis fistula on planned access arm
4. Subject has a known subclavian stenosis or occlusion
5. Subject has a previous subclavian stent or previous subclavian intervention
6. Subject has a shunt in the radial artery on the planned access arm
7. Subject has evidence of osteomyelitis
8. Subject is currently participating in an investigational drug or device study
9. Subject is pregnant within the study period

Index Procedure Exclusion Criteria

1. Physician unable to obtain radial artery access
2. Physician determines TRA is not acceptable due to patient anatomy, lesion characteristics, and/or disease severity
3. OAS use not attempted (defined as ViperWire introduced into the body)

   Prior to insertion of ViperWire:
4. Femoral access is obtained
5. Unsuccessful peripheral intervention
6. A reportable adverse event has occurred

Primary outcomes:
measure: Procedural Success:
timeFrame: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)
Secondary outcomes:
measure: Treatment Success:
timeFrame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South - Lafayette General South West OBL
state: Louisiana
city: Chesterfield
country: United States
facility: Mercy Hospital, Springfield
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian
state: New York
city: New York
country: United States
facility: Sorin Medical, P.C.
state: New York
Study officials:
References:
citation: Lodha A, Giannopoulos S, Sumar R, Ratcliffe J, Gorenchtein M, Green P, Rollefson W, Stout CL, Armstrong EJ. Transradial Endovascular Intervention: Results From the Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention (REACH PVI) Study. Cardiovasc Revasc Med. 2022 Mar;36:115-120. doi: 10.1016/j.carrev.2021.05.011. Epub 2021 May 15.