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

• Sponsor: Cardiovascular Systems Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03943160
• Collaborator: (none)
• Enrollment: 50
• Locations: 6
• Actual Duration (Months): 6
• Patients Per Site: 8.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease	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 Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
• Actual Study Start Date: Jun 11, 2019
• Actual Primary Completion Date: Dec 11, 2019
• Actual Study Completion Date: Dec 11, 2019

Outcome Measures

Primary Outcome Measures

1. Procedural Success: [Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)]

   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.

Secondary Outcome Measures

1. Treatment Success: [Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. Femoral access is obtained

2. Unsuccessful peripheral intervention

3. A reportable adverse event has occurred

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cardiovascular Research Center	Phoenix	Arizona	United States	85016
2	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
3	Cardiovascular Institute of the South - Lafayette General South West OBL	Lafayette	Louisiana	United States	70506
4	Mercy Hospital, Springfield	Chesterfield	Missouri	United States	63017
5	Columbia University Medical Center/New York Presbyterian	New York	New York	United States	10032
6	Sorin Medical, P.C.	New York	New York	United States	10065

Sponsors and Collaborators

• Cardiovascular Systems Inc

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 29, 2019
• Statistical Analysis Plan - Nov 19, 2019

More Information

Publications

None provided.

• Responsible Party: Cardiovascular Systems Inc
• ClinicalTrials.gov Identifier: NCT03943160
• Other Study ID Numbers: CLN-0012-P
• First Posted: May 9, 2019
• Last Update Posted: Jun 11, 2021
• Last Verified: Jun 1, 2021

• 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
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

Participant Flow

Pre-assignment Detail	Following physician assessment of patient and general inclusion/exclusion and informed consent signature, subjects were eligible for enrollment pending index procedure inclusion and exclusion criteria.

Arm/Group Title	OAS Use Via Transradial Access (TRA)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	OAS Use Via Transradial Access (TRA)
Arm/Group Description	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.
Overall Participants	50
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	70.9 (10.3)
Sex: Female, Male (Count of Participants)
Female	14 28%
Male	36 72%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 10%
Not Hispanic or Latino	40 80%
Unknown or Not Reported	5 10%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 2%
Black or African American	10 20%
White	33 66%
Other	2 4%
Unknown or Not Reported	4 8%
Region of Enrollment (Count of Participants)
United States	50 100%
Baseline Rutherford Clinical Category (Count of Participants)
Moderate Claudication (2)	6 12%
Severe Claudication (3)	31 62%
Ischemic Rest Pain (4)	12 24%
Minor Tissue Loss (5)	1 2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OAS Use Via Transradial Access (TRA)
Arm/Group Description	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.
Measure Participants	50
Count of Participants [Participants]	49 98%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OAS Use Via Transradial Access (TRA)
Arm/Group Description	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.
Measure Participants	50
Count of Participants [Participants]	49 98%

Adverse Events

Time Frame	The reporting of adverse events (AEs) began immediately after the subject was enrolled through the first standard of care follow-up visit (7 - 45 days post-procedure). For the purposes of this study, pre-planned interventions noted at baseline were not considered reportable AEs.
Adverse Event Reporting Description	Adverse events were limited to: SAEs, TRA Related Events, Significant Angiographic Events and OAS and ViperCath device related serious injuries. The reporting of AEs began immediately after the subject was enrolled through study exit.
Arm/Group Title	OAS Use Via Transradial Access (TRA)
Arm/Group Description	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.
All Cause Mortality
	OAS Use Via Transradial Access (TRA)
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	OAS Use Via Transradial Access (TRA)
	Affected / at Risk (%)	# Events
Total	2/50 (4%)
Injury, poisoning and procedural complications
Procedural Complications, Lower Extremities	1/50 (2%)	1
Vascular disorders
Lower Extremity Disorders	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	OAS Use Via Transradial Access (TRA)
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.