Clinical trial NCT01937351: Evaluation of the Pantheris Atherectomy System
Official title: Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Atherectomy
Optical Coherence Tomography
Lumivascular
Lead sponsor: Avinger, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-09
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.

Detailed description: The trial will enroll up to 173 subjects diagnosed with peripheral arterial disease of the lower extremities at up to 20 sites (up to 3 international sites), including 133 Intention to Treat subjects and up to 2 additional Roll-In subjects at each site (up to 40 Roll-In subjects total). The primary disease must be located in reference vessel diameters ≥ 2.5 mm and ≤ 7.0 mm. Trial success is focused on safety including rates of major adverse events through 6 months as adjudicated by a Clinical Events Committee. Effectiveness will be evaluated using technical success, defined as the percent of target lesions that have a residual diameter stenosis \<50% post-treatment with the Pantheris device alone as assessed by Angiographic Core Lab.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old;
* Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs;
* Subject is willing and able to give informed consent;
* Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5;
* Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation;
* Subject has de novo target lesion(s) with stenosis \>70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device;
* Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in total length);
* Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days and 6 months;
* At least one patent tibial run-off vessel at baseline.

Inclusion Criteria for the 24-month follow up:

* Completed the 6-month follow-up visit
* Re-consented prior to the 24-month follow-up visit

Exclusion Criteria:

* Subject is pregnant or breast feeding;
* Rutherford Class 0 to 1 (asymptomatic and mild claudication);
* Rutherford Class 6 (critical limb ischemia);
* Moderate to severe calcification of the target lesion;
* Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment;
* In-stent restenosis within the target lesion;
* Target lesion with any type of stent or graft;
* Target lesion in the iliac artery;
* Target lesion stenosis \<70%;
* Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion;
* Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure;
* Planned endovascular or surgical procedure 30 days after the index procedure;
* Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure;
* Subjects with active systemic infections whether they are being currently treated or not;
* Subjects on chronic hemodialysis or creatinine level \>2.0mg/dL;
* Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
* Evidence or history of aneurysmal target vessel within the past 2 months;
* History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days;
* Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated;
* Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated;
* History of heparin-induced thrombocytopenia (HIT);
* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2, known coagulopathy, or International Normalized Ratio (INR) \>1.5;
* Any thrombolytic therapy within 2 weeks of the index procedure;
* Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject;
* Subjects or their legal guardians who have not or will not sign the Informed Consent;
* Subjects who are unwilling or unable to comply with the follow-up study requirements;
* Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: Day 0 through 6 Months
measure: Primary Effectiveness Endpoint: Technical Success
timeFrame: Day 0
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: Day 0 through Day 30
measure: Secondary Safety Endpoint
timeFrame: Day 0 through 30 days
measure: Secondary Safety Endpoint
timeFrame: Day 0 through 6 Months
measure: Secondary Effectiveness Endpoint: Procedural Success
timeFrame: Day 0
measure: Secondary Effectiveness Endpoint: ABI
timeFrame: Day 30
measure: Secondary Effectiveness Endpoint: Rutherford Classification
timeFrame: Day 30
measure: Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
timeFrame: Day 30
measure: Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
timeFrame: Day 30
measure: Secondary Effectiveness Endpoint: ABI
timeFrame: 6 Month
measure: Secondary Effectiveness Endpoint: Rutherford Classification
timeFrame: 6 Month
measure: Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
timeFrame: 6 Month
measure: Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
timeFrame: 6 Month
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: West Hollywood
country: United States
facility: Cedars Sinai Medical Center/Cardiovascular Research Foundation of Southern California
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital
state: District of Columbia
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center, Cardiovascular Associates
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Hospital and Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: St. Joseph's Hospital
state: Indiana
city: Detroit
country: United States
facility: Detroit Medical Center Cardiovascular Institute Harper-Hutzel Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Jackson
country: United States
facility: St. Dominic Hospital
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: New Brunswick
country: United States
facility: St. Peters University Hospital
state: New Jersey
city: Cincinnati
country: United States
facility: Hatton Institute for Research and Education, Good Samaritan Hospital - Bethesda North
state: Ohio
city: Dayton
country: United States
facility: Dayton Heart Center/Good Samaritan Hospital
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Center
state: Ohio
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist Hospital
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Muenster
country: Germany
facility: Muenster Hospital
Study officials:
affiliation: Jackson Heart Clinic
name: Gray Bennett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jackson Heart Clinic
name: Billy Crowder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muenster Hospital
name: Arne Schwindt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10.