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

Peripheral Artery Disease Clinical Trial

— REACH PVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943160
• Other study ID #: CLN-0012-P
• Status: Completed
• Start date: June 11, 2019
• Est. completion date: December 11, 2019

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mercy Hospital, Springfield	Chesterfield	Missouri
United States	Cardiovascular Institute of the South - Lafayette General South West OBL	Lafayette	Louisiana
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Columbia University Medical Center/New York Presbyterian	New York	New York
United States	Sorin Medical, P.C.	New York	New York
United States	Arizona Cardiovascular Research Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & 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 (RE — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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