DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions (REALITY)
Peripheral Vascular Disease
Device: Medtronic HawkOne® or TurboHawk™
Device: Medtronic IN.PACT® Admiral® DCB
Device: Medtronic Spider™ Distal Protection Device (DPD)
Device: Volcano Visions® PV .014" IVUS catheter
Device: Nitinol Stent Placement
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The REALITY Study: DiRectional AthErectomy + Drug-CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions|
- Primary Patency [ Time Frame: One year ]One-year primary patency (PSVR ≤2.4) and freedom from CD-TLR in subjects with long, moderate and severely calcified symptomatic femoropopliteal arterial stenoses and occlusions after treatment with DA+DCB.
- Freedom from MAE [ Time Frame: One month ]Freedom from (MAEs) defined as freedom from flow-limiting dissections (D-F), vessel perforations, unplanned amputation, intra-procedure distal athero-embolization and clinically-driven TVR in subjects with long, moderate and severely calcified femoropopliteal lesions and occlusions through 30 day follow up.
- Device Success [ Time Frame: Post Index Procedure ]Device Success: ≤ 30% residual stenosis after completion of directional atherectomy procedure (stand-alone) as assessed by the angiographic core lab.
- Procedural Success [ Time Frame: Post Index Procedure ]Procedural Success: ≤30% residual stenosis after completion of the directional atherectomy procedure and DCB as assessed by the angiographic core lab.
- IVUS [ Time Frame: Post Index Procedure ]Core lab assessed correlation between IVUS metrics of luminal diameter, change in plaque area and luminal gain pre- and post-atherectomy, and angiographic core lab assessment of pre- and post-percent diameter stenosis (%DS) and the extent of vascular calcification will be determined
- PACCS scoring and related procedural complications [ Time Frame: 1 month ]The association of moderate and severe calcification as defined by the Peripheral Arterial Calcium Scoring System (PACSS) and the change in %DS, procedure related complications (residual stenosis ≥50%, vessel recoil and/or high-grade dissections requiring use of adjunct technologies) visual quantification of embolic material in the distal protection device and MAEs through 30-days will be assessed
- Directional Atherectomy [ Time Frame: Post Index Procedure ]Directional Atherectomy device specific metrics of total directional atherectomy time as a function of lesion length, lesion morphology, and total procedure time.
- Major Adverse Events thru 24 months [ Time Frame: 24 months ]Major adverse events through 24-months defined as composite clinically-driven target lesion revascularization (CD-TVR) defined as any re-intervention within the target vessel due to symptoms associated with a drop from post-intervention ABI/TBI >20% or >0.15, major unplanned amputation of the treated limb, and all-cause mortality post 30 day follow up through 2 year follow up.
- Post procedure TVR [ Time Frame: 6, 12, 24 months ]TVR within 6, 12, 24 months post index procedure
- CD-TLR post procedure [ Time Frame: 6, 12, 24 months ]TLR within 6, 12, 24 months post index procedure
- Time to CD-TLR thru 24 months post procedure [ Time Frame: 24 months ]Time to first clinically-driven target lesion revascularization (TLR) through 24 months post-index procedure
- Major target limb amputation post procedure [ Time Frame: 6, 12, 24 months ]Major target limb amputation within 6, 12, 24 months post index procedure
- Thrombosis- target lesion post procedure [ Time Frame: 6, 12, 24 months ]Thrombosis at the target lesion site within 6, 12, 24 months post index procedure
- Primary sustained clinical improvement [ Time Frame: 6, 12, 24 months ]Primary sustained clinical improvement: An improvement shift in the Rutherford classification of at least one class in amputation- and TVR-free surviving subjects at 6, 12, 24 months post procedure
- Secondary sustained clinical improvement [ Time Frame: 6, 12, 24 months ]Secondary sustained clinical improvement: An improvement shift in the Rutherford classification of at least one class including the need for clinically-driven TVR in amputation-free surviving subjects at 6, 12, 24 months post index procedure
|Study Start Date:||June 2016|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Directional Atherectomy + Drug Coated Balloon: DA followed by DCB will be performed in all enrolled subjects.
DA includes the use of Intervention 'Medtronic HawkOne® or TurboHawk™.
Medtronic Spider™ Distal Protection Device (DPD) is recommended for use according to IFU.
Medtronic IN.PACT® Admiral® DCB will be used after DA.
Volcano Visions® PV .014" IVUS catheter required to assess lesion in each procedure.
Nitinol Stent Placement: Only FDA approved nitinol stents can be used if provisional stenting is required.
Device: Medtronic HawkOne® or TurboHawk™
Use of FDA Cleared Directional Atherectomy (DA) Devices. Medtronic HawkOne® Directional Atherectomy System or TurboHawk™ Plaque Excision System. DA followed by DCB will be performed in all enrolled subjects.Device: Medtronic IN.PACT® Admiral® DCB
FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.Device: Medtronic Spider™ Distal Protection Device (DPD)
It is recommended that the Medtronic Spider™ Distal protection device (DPD) be paired with DA when used in complex, calcified lesions (TurboHawk™ IFU).Device: Volcano Visions® PV .014" IVUS catheter
Lesion IVUS assessment using the Volcano Visions® PV .014" IVUS catheter will be required in all cases.Device: Nitinol Stent Placement
Only FDA approved nitinol stents can be used if provisional stenting is required.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02850107
|Contact: Krishna Singh, MD||217-788-0706||Krs@Krsingh.com|
|Contact: Brian DeRubertis, MDemail@example.com|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27607|
|Contact: Ravish Sachar, MD 919-787-5380 Ravish.Sachar@unchealth.unc.edu|
|Contact: Diana Rhyne, RN 919-740-4897 firstname.lastname@example.org|
|United States, Texas|
|Austin, Texas, United States, 78756|
|Contact: Roger Gammon, MD 512-206-3600 Roger.Gammon@hcahealthcare.com|
|Contact: Frank Zidar, MD 512-206-3600 Frank.Zidar@hcahealthcare.com|
|DCOL||Active, not recruiting|
|Longview, Texas, United States, 75605|
|Principal Investigator:||Krishna Singh, MD||VIVA Physicians, Inc.|