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

Abbott

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Device: Diamondback 360 Extended Length Orbital Atherectomy System

Study type: Observational

Funder types: Industry

Identifiers

NCT03943160

CLN-0012-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design