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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Diamondback 360 Extended Length Orbital Atherectomy System

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Cardiovascular Research Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • Louisiana
    • Lafayette, Louisiana, United States, 70506
      • Cardiovascular Institute of the South - Lafayette General South West OBL
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Mercy Hospital, Springfield
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/New York Presbyterian
    • New York, New York, United States, 10065
      • Sorin Medical, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success:	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.	Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Success:	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.	Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): December 11, 2019
• Study Completion (Actual): December 11, 2019

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: CLN-0012-P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No