Clinical trial NCT02850107: DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions
Official title: The REALITY Study: DiRectional AthErectomy + Drug-CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: Atherectomy, Drug-Coated Balloon
Lead sponsor: VIVA Physicians
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-07-29
Enrollment: 102
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: This study is designed to collect information during a procedure that is routine care for treating a blockage in a blood vessel in the upper part of the participant's leg. This study is for data collection reasons to help doctors gain better understanding of the treatment of disease in the blood vessels of the legs. You will be treated with two devices that are routine, or standard of care, for your doctor to treat blockages in the blood vessel of the leg. The treatment is for a blockage or narrowing caused by plaque build-up in the blood vessel. Data will be collected to assess what length of time the blood vessel will be prevented from re-narrowing through twenty-four (24) months after the procedure.

Detailed description: This prospective study will evaluate the safety and effectiveness of two FDA 510(k) cleared DA products (Medtronic HawkOne® and TurboHawkM)19-21 and FDA approved drug-coated balloon (Medtronic IN.PACT® Admiral®)22 used in combination to debulk moderate and severely calcified femoropopliteal artery atherosclerotic lesions as defined by the published Peripheral Arterial Calcium Scoring System (PACSS) followed by treatment with the Medtronic IN.PACT® Admiral® DCB for the prevention of restenosis as assessed at 12-month follow-up. The data will be independently adjudicated by an angiographic and DUS core labs. An independent IVUS core lab to determine change in maximal luminal plaque area, pre- and post-atherectomy and post-adjunctive DCB therapy will adjudicate the assessment of debulking effectiveness. The operator will be blinded to all IVUS images and procedural success will be based on usual and customary angiographic visual assessments. The post-atherectomy plaque debulking effectiveness (change in plaque area) and vascular calcium severity as assessed by IVUS will be correlated with the angiographic metrics of RVD, pre- and post-treatment MLD, calcium grade (using PACSS), lesion length, sub-intimal wire passage, CTO length, and angiographic patterns of restenosis in all patients who sustain a CD-TLR through 12-months. All atherectomy specimens will be collected and provided to an independent histology laboratory for analysis of calcium content and vessel wall elements. The amount of embolic debris captured in the Spider® Distal Protection Device will be visually assessed. The study will validate PACSS definitions of moderate and severe calcium and its location (intimal, medial or mixed) as they relate to intra-procedural and Major Adverse Events (MAEs) through 30-day clinical follow-up (e.g., grade D-F dissections requiring provisional stenting, vessel perforation requiring an additional intervention or surgery, vessel thrombosis requiring adjunctive technologies and/or lytic agents, unplanned amputation, intra-procedure distal embolization, and CD-TLR).

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria:

1. Willing and able to provide informed consent;
2. Age ≥ 18 years of age;
3. Clinical evaluation determines Rutherford Category 2-4;
4. Willing to comply with all study requirements;
5. All lab work is within acceptable limits to undergo a percutaneous interventional procedure.
6. Life expectancy, in the investigator's opinion, of at least 24 months.

Angiographic Inclusion Criteria:

1. RVD ≥ 4mm and ≤ 7mm;
2. Evidence of a ≥70% de novo or restenotic lesion or occlusion in the target lesion defined as in the superficial femoral artery and/or popliteal artery, located in the arterial segment starting at least 1 cm beyond the Common Femoral Artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark) to the distal P2 segment of the popliteal artery;
3. Total lesion/occlusion length:

   a. ≥ 8 cm and ≤ 18 cm
4. Total occlusion length

   a. ≥ 6 cm and ≤10 cm
5. Stenosis or occlusion begins 1cm below the profunda-SFA bifurcation;
6. Femoral or popliteal stenosis or occlusion that does not extend beyond the P2 popliteal segment;
7. Minimum 1 patent infrapopliteal vessel to the foot with ≤ 50% diameter stenosis;
8. Grade 3 or 4 intimal, medial and/or mixed calcification per the PACSS as judged by the operator at the time of the procedure;
9. Index lesion fits within guidelines below:

   9.1 If two lesions are ≤ 3 cm apart, treatment would be allowed as a single lesion providing they contain a segment of moderate or severe calcification and the total lesion length is ≥ 8 cm and ≤18 cm.

   9.2 If more than one lesion is within the target vessel, and they are separated by \> 3 cm of normal vessel, one lesion must be designated by the investigator as the target lesion as long as the lesion meets all angiographic eligibility criteria. Only one index lesion is permitted for analysis, but study will allow a second lesion to be treated as a non-target lesion.
10. Infrapopliteal lesion, if diagnosed, can be staged and treated \> 30 days after index procedure.

Exclusion Criteria:

General Exclusion Criteria:

1. Renal failure or chronic kidney disease with GFR ≤30 ml/min or MDRD GFR ≤30 ml/min per 1.73m2 (and serum creatinine ≥2.5 mg/dL within 30 days of index procedure);
2. Physician does not believe subject is an appropriate candidate for study;
3. Previous infra-inguinal intervention in the index limb within 30 days of the planned femoropopliteal intervention

Angiographic Exclusion Criteria:

1. Inability to cross lesion/occlusion with a guidewire or re-entry device;
2. Inability for the guidewire to re-enter and/or remain in the true lumen prior to enrollment;
3. In-stent restenosis of the target lesion, or recognition of any stent (patent or re-stenotic within the femoropopliteal segment of the index limb;
4. Aneurysm located in the target vessel or aneurysmal vessel;
5. Acute thrombus in the index limb prior to enrollment.

Primary outcomes:
measure: Primary Patency
timeFrame: One year
measure: Freedom from MAE
timeFrame: One month
Secondary outcomes:
measure: Device Success
timeFrame: Post Index Procedure
measure: Procedural Success
timeFrame: Post Index Procedure
measure: IVUS
timeFrame: Post Index Procedure
measure: PACCS scoring and related procedural complications
timeFrame: 1 month
measure: Directional Atherectomy
timeFrame: Post Index Procedure
measure: Major Adverse Events thru 24 months
timeFrame: 24 months
measure: Post procedure TVR
timeFrame: 6, 12, 24 months
measure: CD-TLR post procedure
timeFrame: 6, 12, 24 months
measure: Time to CD-TLR thru 24 months post procedure
timeFrame: 24 months
measure: Major target limb amputation post procedure
timeFrame: 6, 12, 24 months
measure: Thrombosis- target lesion post procedure
timeFrame: 6, 12, 24 months
measure: Primary sustained clinical improvement
timeFrame: 6, 12, 24 months
measure: Secondary sustained clinical improvement
timeFrame: 6, 12, 24 months
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Boston
country: United States
facility: St. Elizabeth's
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Raleigh
country: United States
facility: Rex
state: North Carolina
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Longview
country: United States
facility: Longview Cardiac and Vascular Consultants
state: Texas
Study officials:
affiliation: VIVA Physicians, Inc.
name: Krishna Singh, MD
role: PRINCIPAL_INVESTIGATOR
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