DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions (REALITY)
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|ClinicalTrials.gov Identifier: NCT02850107|
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The REALITY Study: DiRectional AthErectomy + Drug-CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions|
|Actual Study Start Date :||June 1, 2016|
|Actual Primary Completion Date :||June 16, 2020|
|Actual Study Completion Date :||June 16, 2020|
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.
- 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
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): NCT02850107
|United States, Iowa|
|Iowa Methodist Medical Center|
|Des Moines, Iowa, United States, 50309|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 2135|
|United States, Mississippi|
|University of Mississippi|
|Jackson, Mississippi, United States, 39216|
|United States, New York|
|New York, New York, United States, 10029|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27607|
|United States, Texas|
|Austin, Texas, United States, 78756|
|Longview Cardiac and Vascular Consultants|
|Longview, Texas, United States, 75605|
|Principal Investigator:||Krishna Singh, MD||VIVA Physicians, Inc.|