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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-11

Study Completion Date

2019-12-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Diamondback 360 Extended Length Orbital Atherectomy System

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.

Intervention Type DEVICE

Other Intervention Names

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Stealth 360 Extended Length Orbital Atherectomy System

Eligibility Criteria

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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

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No