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出境医 / 临床实验 / Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI (REACH PVI)

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

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
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
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 3, 2019
First Posted Date May 9, 2019
Results First Submitted Date February 3, 2021
Results First Posted Date March 3, 2021
Last Update Posted Date March 3, 2021
Actual Study Start Date June 11, 2019
Actual Primary Completion Date December 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2021) 		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.
Original Primary Outcome Measures
 (submitted: May 7, 2019) 		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.
Change History
Current Secondary Outcome Measures
 (submitted: March 1, 2021) 		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.
Original Secondary Outcome Measures
 (submitted: May 7, 2019) 		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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
Official Title Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
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.
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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Other Name: Stealth 360 Extended Length Orbital Atherectomy System
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2019) 		50
Original Estimated Enrollment Same as current
Actual Study Completion Date December 11, 2019
Actual Primary Completion Date December 11, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03943160
Other Study ID Numbers CLN-0012-P
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Cardiovascular Systems Inc
Study Sponsor Cardiovascular Systems Inc
Collaborators Not Provided
Investigators Not Provided
PRS Account Cardiovascular Systems Inc
Verification Date March 2021