Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization

NCT02961894 | Completed Results DMC FDA Device

• 1 other identifier: REX-US-2017-001
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 17

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.

Conditions

Peripheral Artery Disease

Keywords

Atherectomy; Atherosclerosis

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint: Number of Participants With Freedom From Major Adverse Events

  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).

  30-Day

• Effectiveness Endpoint: Technical Success

  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.

  1-Day

Secondary Outcomes (13)

• Target Lesion Revascularization (TLR) Rate

  30 Days

• Change in % Stenosis

  1-Day

• Procedural Success

  1-Day

• Assessment of the Combined Components of the Primary Safety Endpoint, Freedom From MAE

  6 months

• Freedom From Target Lesion Revascularization (TLR) Rate

  6 months

Study Arms (1)

Revolution Treatment Arm

EXPERIMENTAL

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

Interventions

Revolution™ Peripheral Atherectomy System DEVICE

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.

Also known as: Revolution Peripheral Atherectomy System, Percutaneous Transluminal Atherectomy, Rotational Atherectomy

Revolution Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects in whom amputation above the ankle is necessary, irrespective of the success of revascularization.
• In-stent restenosis within the target lesion.
• Flow-limiting dissection, Type C or greater.
• Target lesions within an autogenous or prosthetic bypass graft.
• History of an endovascular procedure or open vascular reconstruction in the index limb within the last 30 days, including thrombolytic therapy.
• 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.
• 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.
• Pregnancy or breast feeding. A woman of child-bearing potential must have a negative pregnancy test within one week of index procedure.
• Myocardial infarction or stroke within 2 months of enrollment.
• Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy.
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \< 125,000/μL, known coagulopathy, or INR \> 1.5.
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pretreated in the opinion of the investigator.
• History of heparin-induced thrombocytopenia.
• Psychiatric disorder which, according to the investigator, has potential to interfere with provision of informed consent, completion of tests, therapy, or follow-up.
• Clinical/angiographic evidence of distal embolization or acute thrombus.

Sponsors & Collaborators

• Rex Medical: lead
• Syntactx: collaborator

Study Sites (17)

Vascular Breakthroughs

Darien, Connecticut, 06820, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Precision Clinical Research

Lauderdale Lakes, Florida, 33319, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32504, United States

Location

St. Joseph's Hospital

Tampa, Florida, 33614, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Community Health

Munster, Indiana, 46321, United States

Location

Michigan Outpatient Vascular Institute

Dearborn, Michigan, 48126, United States

Location

Vascular Access Center

Mays Landing, New Jersey, 08330, United States

Location

North Carolina Heart and Vascular

Raleigh, North Carolina, 27607, United States

Location

Allegheny Vein & Vascular

Bradford, Pennsylvania, 16701, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Pennsylvania Vascular Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Anderson Heart

Anderson, South Carolina, 29621, United States

Location

DFW Vascular Group

Dallas, Texas, 75208, United States

Location

Houston Heart and Vascular

Kingwood, Texas, 77339, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

Related Publications (1)

• Carr J, Bowman J, Watts M, Ouriel K, Dave R. United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System. J Vasc Surg. 2022 Mar;75(3):976-986.e4. doi: 10.1016/j.jvs.2021.08.107. Epub 2021 Oct 5.

  PMID: 34624496 DERIVED

Related Links

• RexMedical.com

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis

Interventions

Atherectomy; Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Myocardial Revascularization; Cardiac Surgical Procedures; Percutaneous Coronary Intervention; Thoracic Surgical Procedures

Results Point of Contact

• Title: Colin Valentis
• Organization: Rex Medical

cvalentis@rexmedical.com

610-629-6051

Study Officials

• Jeffrey G Carr, MD

  Cardiovascular Associates of East Texas

  PRINCIPAL INVESTIGATOR

• Kenneth Ouriel, MD

  Syntactx

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 11, 2016
• Study Start: June 7, 2017
• Primary Completion: February 28, 2019
• Study Completion: September 20, 2019
• Last Updated: November 2, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)