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Trial record 1 of 7 for:    Reach PVI
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Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI (REACH PVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943160
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc

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
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.

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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 : June 11, 2019
Actual Primary Completion Date : December 11, 2019
Actual Study Completion Date : December 11, 2019

Intervention Details:
  • 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.
    Other Name: Stealth 360 Extended Length Orbital Atherectomy System


Primary Outcome Measures :
  1. Procedural Success: [ Time Frame: Participants will be followed from baseline procedure through hospital discharge, an expected average of 24 hours ]
    Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access related events.


Secondary Outcome Measures :
  1. Treatment Success: [ Time Frame: Intra-procedural time measured as the interval between first arterial access, and removal of arterial access ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943160


Locations
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United States, Arizona
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, Louisiana
Cardiovascular Institute of the South - Lafayette General South West OBL
Lafayette, Louisiana, United States, 70506
United States, Missouri
Mercy Hospital, Springfield
Chesterfield, Missouri, United States, 63017
United States, New York
Columbia University Medical Center/New York Presbyterian
New York, New York, United States, 10032
Sorin Medical, P.C.
New York, New York, United States, 10065
Sponsors and Collaborators
Cardiovascular Systems Inc
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Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT03943160    
Other Study ID Numbers: CLN-0012-P
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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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:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases