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

NCT03943160 | Completed Results FDA Device

• 1 other identifier: CLN-0012-P
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment Success:

  Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Interventions

Diamondback 360 Extended Length Orbital Atherectomy System DEVICE

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.

Also known as: Stealth 360 Extended Length Orbital Atherectomy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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
• 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
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Cardiovascular Institute of the South - Lafayette General South West OBL

Lafayette, Louisiana, 70506, United States

Location

Mercy Hospital, Springfield

Chesterfield, Missouri, 63017, United States

Location

Columbia University Medical Center/New York Presbyterian

New York, New York, 10032, United States

Location

Sorin Medical, P.C.

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 34020900 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Cardiovascular Systems Inc.

clinicaltrials_csi@csi360.com

651.259.2500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 9, 2019
• Study Start: June 11, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: July 18, 2023
• Results First Posted: March 3, 2021

Record last verified: 2023-07

Locations

US (6)