- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03943160
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI (REACH PVI)
July 14, 2023 updated by: Abbott Medical Devices
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
-
Phoenix, Arizona, United States, 85016
- Arizona Cardiovascular Research Center
-
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Arkansas Heart Hospital
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Louisiana
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Lafayette, Louisiana, United States, 70506
- Cardiovascular Institute of the South - Lafayette General South West OBL
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Missouri
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Chesterfield, Missouri, United States, 63017
- Mercy Hospital, Springfield
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center/New York Presbyterian
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New York, New York, United States, 10065
- Sorin Medical, P.C.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Index Procedure Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Index Procedure Exclusion Criteria
- 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
- A reportable adverse event has occurred
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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:
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)
|
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:
Time Frame: 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.
|
Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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