DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions

NCT02850107 | Completed

• 1 other identifier: VIVA-CLIN-2016-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 7

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.

Conditions

Peripheral Vascular Disease

Keywords

Atherectomy, Drug-Coated Balloon

Outcome Measures

Primary Outcomes (2)

• Primary Patency

  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.

  One year

• Freedom from MAE

  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.

  One month

Secondary Outcomes (13)

• Device Success

  Post Index Procedure

• Procedural Success

  Post Index Procedure

• IVUS

  Post Index Procedure

• PACCS scoring and related procedural complications

  1 month

• Directional Atherectomy

  Post Index Procedure

Study Arms (1)

Non-randomized

OTHER

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™; Device: Medtronic IN.PACT® Admiral® DCB; Device: Medtronic Spider™ Distal Protection Device (DPD); Device: Volcano Visions® PV .014" IVUS catheter; Device: Nitinol Stent Placement

Interventions

Medtronic HawkOne® or TurboHawk™ DEVICE

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.

Non-randomized

Medtronic IN.PACT® Admiral® DCB DEVICE

FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.

Non-randomized

Medtronic Spider™ Distal Protection Device (DPD) DEVICE

It is recommended that the Medtronic Spider™ Distal protection device (DPD) be paired with DA when used in complex, calcified lesions (TurboHawk™ IFU).

Non-randomized

Volcano Visions® PV .014" IVUS catheter DEVICE

Lesion IVUS assessment using the Volcano Visions® PV .014" IVUS catheter will be required in all cases.

Non-randomized

Nitinol Stent Placement DEVICE

Only FDA approved nitinol stents can be used if provisional stenting is required.

Non-randomized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent;
• Age ≥ 18 years of age;
• Clinical evaluation determines Rutherford Category 2-4;
• Willing to comply with all study requirements;
• All lab work is within acceptable limits to undergo a percutaneous interventional procedure.
• Life expectancy, in the investigator's opinion, of at least 24 months.
• RVD ≥ 4mm and ≤ 7mm;
• 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;
• Total lesion/occlusion length:
• a. ≥ 8 cm and ≤ 18 cm
• Total occlusion length
• a. ≥ 6 cm and ≤10 cm
• Stenosis or occlusion begins 1cm below the profunda-SFA bifurcation;
• Femoral or popliteal stenosis or occlusion that does not extend beyond the P2 popliteal segment;
• Minimum 1 patent infrapopliteal vessel to the foot with ≤ 50% diameter stenosis;

You may not qualify if:

• 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);
• Physician does not believe subject is an appropriate candidate for study;
• Previous infra-inguinal intervention in the index limb within 30 days of the planned femoropopliteal intervention
• Inability to cross lesion/occlusion with a guidewire or re-entry device;
• Inability for the guidewire to re-enter and/or remain in the true lumen prior to enrollment;
• In-stent restenosis of the target lesion, or recognition of any stent (patent or re-stenotic within the femoropopliteal segment of the index limb;
• Aneurysm located in the target vessel or aneurysmal vessel;
• Acute thrombus in the index limb prior to enrollment.

Sponsors & Collaborators

• VIVA Physicians: lead
• Medtronic: collaborator

Study Sites (7)

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

St. Elizabeth's

Boston, Massachusetts, 2135, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Rex

Raleigh, North Carolina, 27607, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Longview Cardiac and Vascular Consultants

Longview, Texas, 75605, United States

Location

Related Publications (18)

• 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.

  PMID: 16908785 RESULT

• 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.

  PMID: 17489079 RESULT

• 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.

  PMID: 22147886 RESULT

• 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.

  PMID: 25147039 RESULT

• 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.

  PMID: 24402764 RESULT

• 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.

  PMID: 23703778 RESULT

• 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.

  PMID: 26106946 RESULT

• 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.

  PMID: 25472980 RESULT

• 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.

  PMID: 26476467 RESULT

• 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.

  PMID: 18272892 RESULT

• 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.

  PMID: 18779447 RESULT

• 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.

  PMID: 23192918 RESULT

• 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.

  PMID: 24456716 RESULT

• 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.

  PMID: 24806955 RESULT

• 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.

  PMID: 24402839 RESULT

• 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.

  PMID: 26250747 RESULT

• 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.

  PMID: 22632996 RESULT

• 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.

  PMID: 34080792 DERIVED

Related Links

• HawkOne 510(k) clearance.
• Turbo Hawk 3 510(k) clearances.

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Krishna Singh, MD

  VIVA Physicians, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 29, 2016
• Study Start: June 1, 2016
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)