DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions
NCT ID: NCT02850107
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2016-06-01
2020-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non-randomized
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.
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.
Medtronic IN.PACT® Admiral® DCB
FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.
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).
Volcano Visions® PV .014" IVUS catheter
Lesion IVUS assessment using the Volcano Visions® PV .014" IVUS catheter will be required in all cases.
Nitinol Stent Placement
Only FDA approved nitinol stents can be used if provisional stenting is required.
Interventions
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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.
Medtronic IN.PACT® Admiral® DCB
FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.
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).
Volcano Visions® PV .014" IVUS catheter
Lesion IVUS assessment using the Volcano Visions® PV .014" IVUS catheter will be required in all cases.
Nitinol Stent Placement
Only FDA approved nitinol stents can be used if provisional stenting is required.
Eligibility Criteria
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Inclusion Criteria
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.
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
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
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.
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
VIVA Physicians
OTHER
Responsible Party
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Principal Investigators
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Krishna Singh, MD
Role: PRINCIPAL_INVESTIGATOR
VIVA Physicians, Inc.
Locations
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Iowa Methodist Medical Center
Des Moines, Iowa, United States
St. Elizabeth's
Boston, Massachusetts, United States
University of Mississippi
Jackson, Mississippi, United States
Mount Sinai
New York, New York, United States
Rex
Raleigh, North Carolina, United States
Austin Heart
Austin, Texas, United States
Longview Cardiac and Vascular Consultants
Longview, Texas, United States
Countries
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References
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Golomb BA, Dang TT, Criqui MH. Peripheral arterial disease: morbidity and mortality implications. Circulation. 2006 Aug 15;114(7):688-99. doi: 10.1161/CIRCULATIONAHA.105.593442. No abstract available.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, Rutherford RB; TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease. Int Angiol. 2007 Jun;26(2):81-157. No abstract available.
Goodney PP, Travis LL, Nallamothu BK, Holman K, Suckow B, Henke PK, Lucas FL, Goodman DC, Birkmeyer JD, Fisher ES. Variation in the use of lower extremity vascular procedures for critical limb ischemia. Circ Cardiovasc Qual Outcomes. 2012 Jan;5(1):94-102. doi: 10.1161/CIRCOUTCOMES.111.962233. Epub 2011 Dec 6.
McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA; DEFINITIVE LE Investigators. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014 Aug;7(8):923-33. doi: 10.1016/j.jcin.2014.05.006.
Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW, Clair D; DEFINITIVE Ca(+)(+) Investigators. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca(+)(+) trial. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):236-44. doi: 10.1002/ccd.25384. Epub 2014 Feb 5.
Yazdani SK, Pacheco E, Nakano M, Otsuka F, Naisbitt S, Kolodgie FD, Ladich E, Rousselle S, Virmani R. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):132-40. doi: 10.1002/ccd.24995. Epub 2013 Jul 3.
Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Muller-Hulsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.
Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB, Alexander B, Landini M, Jaff MR; IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015 Feb 3;131(5):495-502. doi: 10.1161/CIRCULATIONAHA.114.011004. Epub 2014 Dec 3.
Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.
Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.
Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hanninen EL. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012 Dec;5(6):831-40. doi: 10.1161/CIRCINTERVENTIONS.112.971630. Epub 2012 Nov 27.
Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.
Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, d'Adamo A, Salvatori FM. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014 Aug;37(4):898-907. doi: 10.1007/s00270-014-0904-3. Epub 2014 May 9.
Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10.
Tepe G, Beschorner U, Ruether C, Fischer I, Pfaffinger P, Noory E, Zeller T. Drug-Eluting Balloon Therapy for Femoropopliteal Occlusive Disease: Predictors of Outcome With a Special Emphasis on Calcium. J Endovasc Ther. 2015 Oct;22(5):727-33. doi: 10.1177/1526602815600156. Epub 2015 Aug 6.
Cioppa A, Stabile E, Popusoi G, Salemme L, Cota L, Pucciarelli A, Ambrosini V, Sorropago G, Tesorio T, Agresta A, Biamino G, Rubino P. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results. Cardiovasc Revasc Med. 2012 Jul-Aug;13(4):219-23. doi: 10.1016/j.carrev.2012.04.007. Epub 2012 May 25.
Rocha-Singh KJ, Sachar R, DeRubertis BG, Nolte-Ernsting CCA, Winscott JG, Krishnan P, Scott EC, Garcia LA, Baeriswyl JL, Ansel G, Rosenfield K, Zeller T; REALITY Investigators. Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study. Catheter Cardiovasc Interv. 2021 Sep;98(3):549-558. doi: 10.1002/ccd.29777. Epub 2021 Jun 3.
Related Links
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HawkOne 510(k) clearance.
Turbo Hawk 3 510(k) clearances.
Other Identifiers
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VIVA-CLIN-2016-01
Identifier Type: -
Identifier Source: org_study_id
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