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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
Results First Posted : November 2, 2020
Last Update Posted : November 2, 2020
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: N/A
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: Number of Participants With 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 percentage of target lesions with technical success.


Secondary Outcome Measures :
  1. Target Lesion Revascularization (TLR) Rate [ Time Frame: 30 Days ]
    Target Lesion Revascularization (TLR) rate through 30 days.

  2. 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.

  3. 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.

  4. Assessment of the Combined Components of the Primary Safety Endpoint, Freedom From MAE [ Time Frame: 6 months ]
    Assessment of the total combined components of the primary safety endpoint (Freedom from 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 6 months.

  5. Freedom From Target Lesion Revascularization (TLR) Rate [ Time Frame: 6 months ]
    Freedom from Target Lesion Revascularization (TLR) rate through 6 months.

  6. Freedom From Myocardial Infarction [ Time Frame: 30 Days ]
    Freedom from Myocardial infarction through 30 days.

  7. Freedom From Myocardial Infarction [ Time Frame: 6 months ]
    Freedom from Myocardial infarction through 6 months.

  8. Freedom From Target Vessel Revascularization (TVR) Rate [ Time Frame: 30 Days ]
    Freedom from incidence of target vessel revascularization (TVR) through 30 days.

  9. Freedom From Target Vessel Revascularization (TVR) Rate [ Time Frame: 6 months ]
    Freedom from incidence of target vessel revascularization (TVR) through 6 months.

  10. Freedom From Angiographic Procedural Distal Embolization [ Time Frame: 1-Day ]
    Freedom from angiographic procedural distal embolization (symptomatic) in the target limb as confirmed angiographically by the core laboratory.

  11. 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.

  12. Assisted Primary 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.

  13. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Show Show 17 study locations
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
  Study Documents (Full-Text)

Documents provided by Rex Medical:
Study Protocol  [PDF] August 1, 2019
Statistical Analysis Plan  [PDF] August 1, 2019

Additional Information:
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Responsible Party: Rex Medical
ClinicalTrials.gov Identifier: NCT02961894    
Other Study ID Numbers: REX-US-2017-001
First Posted: November 11, 2016    Key Record Dates
Results First Posted: November 2, 2020
Last Update Posted: November 2, 2020
Last Verified: October 2020
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
Keywords provided by Rex Medical:
Atherectomy
Atherosclerosis
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases