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Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization (REVEAL)

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: NCT02961894
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
Rex Medical

Brief Summary:

To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.

This Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and the presence of any major adverse events (safety) for up to 30 days after the procedure.


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: Revolution™ Peripheral Atherectomy System Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : September 20, 2019

Arm Intervention/treatment
Experimental: Revolution Treatment Arm
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Device: Revolution™ Peripheral Atherectomy System
The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
Other Names:
  • Revolution Peripheral Atherectomy System
  • Percutaneous Transluminal Atherectomy
  • Rotational Atherectomy




Primary Outcome Measures :
  1. Safety Endpoint: Freedom from Major Adverse Events [ Time Frame: 30-Day ]
    Freedom from Major Adverse Events is defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair, and clinically-significant distal embolization in the target limb; as adjudicated by an independent Clinical Events Committee The primary safety endpoint is freedom from 30-day Major Adverse Events (MAE), defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair and clinically-significant distal embolization in the target limb; as adjudicated by the independent Clinical Events Committee (CEC).

  2. Effectiveness Endpoint: Technical Success [ Time Frame: 1-Day ]
    Technical success is defined by ≤50% diameter stenosis after atherectomy with the Revolution™ Peripheral Atherectomy System and prior to adjunctive therapy, as measured by the independent core laboratory on the post-atherectomy contrast angiogram. Effectiveness will be assessed for investigator-identified target lesions and will be calculated as a binary variable as the proportion of target lesions with technical success.


Secondary Outcome Measures :
  1. Change in % stenosis [ Time Frame: 1-Day ]
    Change in % stenosis after treatment with Revolution™ Peripheral Atherectomy System, determined after atherectomy and prior to other adjunctive therapies, as measured by the angiographic core laboratory.

  2. Procedural success [ Time Frame: 1-Day ]
    Procedural success as defined by target lesion residual stenosis of <30% at the conclusion of the index procedure, after atherectomy and any adjunctive endovascular treatment, as measured by the angiographic core laboratory.

  3. Assessment of the individual components of the primary safety endpoint (MAE) [ Time Frame: 30 Days, 6 months ]
    Assessment of the individual components of the primary safety endpoint (MAE); including all-cause mortality, major target limb amputation, clinically significant distal embolization, major target vessel perforation requiring surgical or endovascular repair, and clinically-driven TLR, measured through 30 days and at 6 months.

  4. Target Lesion Revascularization (TLR) Rate [ Time Frame: 30 Days, 6 months ]
    Minor unplanned target limb amputation rate through 30 days and 6 months.

  5. Myocardial infarction [ Time Frame: 30 Days, 6 months ]
    Myocardial infarction through 30 days and 6 months.

  6. Target Vessel Revascularization (TVR) Rate [ Time Frame: 30 Days, 6 months ]
    Incidence of target vessel revascularization (TVR) through 30 days and 6 months.

  7. Angiographic procedural distal embolization [ Time Frame: 1-Day ]
    Frequency of angiographic procedural distal embolization (symptomatic) in the target limb as confirmed angiographically by the core laboratory.

  8. Primary patency [ Time Frame: 30 Days, 6 months ]
    Primary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.

  9. Primary assisted patency [ Time Frame: 30 Days, 6 months ]
    Primary-assisted patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.

  10. Secondary patency [ Time Frame: 30 Days, 6 months ]
    Secondary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.



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
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Willing and able to provide informed consent.
  3. Ability to take at least one form of anti-platelet therapy.
  4. Rutherford categories 2 to 5 in the target limb.
  5. Lesions to be treated with the study device must be located in the same limb.
  6. Target lesion(s) located within the superficial femoral, popliteal or tibial arteries.
  7. Target lesion(s) with stenosis ≥70% diameter reduction as measured by site-reported angiography.
  8. Target lesion length(s) ≤150 mm.
  9. Target lesions(s) with reference vessel diameter (proximal and distal to target lesion) ≥2.0 mm and ≤4.0 mm.

Exclusion Criteria:

  1. Subjects in whom amputation above the ankle is necessary, irrespective of the success of revascularization.
  2. In-stent restenosis within the target lesion.
  3. Flow-limiting dissection, Type C or greater.
  4. Target lesions within an autogenous or prosthetic bypass graft.
  5. History of an endovascular procedure or open vascular reconstruction in the index limb within the last 30 days, including thrombolytic therapy.
  6. Any open vascular surgical procedure planned in the target limb or endovascular procedures planned in the target vessel within 30 days after the index procedure.
  7. Kidney disease of sufficient severity, in the Investigator's opinion, to contraindicate lower extremity angiography using standard or alternate contrast agents as per the local Standard of Care.
  8. Pregnancy or breast feeding. A woman of child-bearing potential must have a negative pregnancy test within one week of index procedure.
  9. Myocardial infarction or stroke within 2 months of enrollment.
  10. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy.
  11. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count < 125,000/μL, known coagulopathy, or INR > 1.5.
  12. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pretreated in the opinion of the investigator.
  13. History of heparin-induced thrombocytopenia.
  14. Psychiatric disorder which, according to the investigator, has potential to interfere with provision of informed consent, completion of tests, therapy, or follow-up.
  15. Clinical/angiographic evidence of distal embolization or acute thrombus.
  16. Significant stenosis (>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (<50% residual stenosis without flow limiting dissection) before the study intervention.

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): NCT02961894


Locations
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United States, Connecticut
Vascular Breakthroughs
Darien, Connecticut, United States, 06820
United States, Florida
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32256
Precision Clinical Research
Lauderdale Lakes, Florida, United States, 33319
Coastal Vascular and Interventional
Pensacola, Florida, United States, 32504
St. Joseph's Hospital
Tampa, Florida, United States, 33614
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Indiana
Community Health
Munster, Indiana, United States, 46321
United States, Michigan
Michigan Outpatient Vascular Institute
Dearborn, Michigan, United States, 48126
United States, New Jersey
Vascular Access Center
Mays Landing, New Jersey, United States, 08330
United States, North Carolina
North Carolina Heart and Vascular
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
Allegheny Vein & Vascular
Bradford, Pennsylvania, United States, 16701
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States, 17011
Pennsylvania Vascular Institute
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Anderson Heart
Anderson, South Carolina, United States, 29621
United States, Texas
DFW Vascular Group
Dallas, Texas, United States, 75208
Houston Heart and Vascular
Kingwood, Texas, United States, 77339
Cardiovascular Associates of East Texas
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Rex Medical
Syntactx
Investigators
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Principal Investigator: Jeffrey G Carr, MD Cardiovascular Associates of East Texas
Study Chair: Kenneth Ouriel, MD Syntactx

Additional Information:
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Responsible Party: Rex Medical
ClinicalTrials.gov Identifier: NCT02961894     History of Changes
Other Study ID Numbers: REX-US-2017-001
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Rex Medical:
Atherectomy
Atherosclerosis
Additional relevant MeSH terms:
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Ivermectin
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Selamectin
Antiparasitic Agents
Anti-Infective Agents