Peripheral Vascular DiseaseREALITYNCT02850107

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

A study testing Medtronic HawkOne® or TurboHawk™, Medtronic IN.PACT® Admiral® DCB and Medtronic Spider™ Distal Protection Device (DPD) in people with Peripheral Vascular Disease, run by VIVA Physicians at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Vascular Disease
What is being tested?: Medtronic HawkOne® or TurboHawk™, Medtronic IN.PACT® Admiral® DCB and Medtronic Spider™ Distal Protection Device (DPD)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 7 sitesUnited States
Study dates: 1 Jun 2016to 16 Jun 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

General Inclusion Criteria:
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.

Show all 22Show fewer

Life expectancy, in the investigator's opinion, of at least 24 months.
Angiographic Inclusion Criteria:
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:
≥ 8 cm and ≤ 18 cm
Total occlusion length
≥ 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;
Grade 3 or 4 intimal, medial and/or mixed calcification per the PACSS as judged by the operator at the time of the procedure;
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.
Infrapopliteal lesion, if diagnosed, can be staged and treated > 30 days after index procedure.

Who cannot join

General Exclusion Criteria:
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
Angiographic Exclusion Criteria:
Inability to cross lesion/occlusion with a guidewire or re-entry device;

Show all 10Show fewer

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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Austin Heart
Austin, Texas, 78756
St. Elizabeth's
Boston, Massachusetts, 2135
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
University of Mississippi
Jackson, Mississippi, 39216
Longview Cardiac and Vascular Consultants
Longview, Texas, 75605
Mount Sinai
New York, New York, 10029
Rex
Raleigh, North Carolina, 27607

Other trials in United States

About this study

Official title: The REALITY Study: DiRectional AthErectomy + Drug-CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions

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.

Read the 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).

Conditions: Peripheral Vascular Disease
Being tested: Medtronic HawkOne® or TurboHawk™, Medtronic IN.PACT® Admiral® DCB, Medtronic Spider™ Distal Protection Device (DPD), Volcano Visions® PV .014" IVUS catheter, Nitinol Stent Placement
Keywords: Atherectomy, Drug-Coated Balloon
Medical subject headings: Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
Medtronic IN.PACT® Admiral® DCBDevice
FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.
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).
Volcano Visions® PV .014" IVUS catheterDevice
Lesion IVUS assessment using the Volcano Visions® PV .014" IVUS catheter will be required in all cases.
Nitinol Stent PlacementDevice
Only FDA approved nitinol stents can be used if provisional stenting is required.

Study groups in NCT02850107
Study group	Role	What they receive
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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: One month

Secondary outcomes (13)

Device Success
Device Success: ≤ 30% residual stenosis after completion of directional atherectomy procedure (stand-alone) as assessed by the angiographic core lab.
Measured: Post Index Procedure
Procedural Success
Procedural Success: ≤30% residual stenosis after completion of the directional atherectomy procedure and DCB as assessed by the angiographic core lab.
Measured: Post Index Procedure
IVUS
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
Measured: Post Index Procedure
PACCS scoring and related procedural complications
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
Measured: 1 month
Directional Atherectomy
Directional Atherectomy device specific metrics of total directional atherectomy time as a function of lesion length, lesion morphology, and total procedure time.
Measured: Post Index Procedure
Major Adverse Events thru 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.
Measured: 24 months
Post procedure TVR
TVR within 6, 12, 24 months post index procedure
Measured: 6, 12, 24 months
CD-TLR post procedure
TLR within 6, 12, 24 months post index procedure
Measured: 6, 12, 24 months
Time to CD-TLR thru 24 months post procedure
Time to first clinically-driven target lesion revascularization (TLR) through 24 months post-index procedure
Measured: 24 months
Major target limb amputation post procedure
Major target limb amputation within 6, 12, 24 months post index procedure
Measured: 6, 12, 24 months
Thrombosis- target lesion post procedure
Thrombosis at the target lesion site within 6, 12, 24 months post index procedure
Measured: 6, 12, 24 months
Primary sustained clinical improvement
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
Measured: 6, 12, 24 months
Secondary sustained clinical improvement
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
Measured: 6, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201616 Jun 2020

First posted29 Jul 2016 (estimated)
Study start1 Jun 2016
Primary completion16 Jun 2020
Study completion16 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02850107
Sponsor's protocol ID: VIVA-CLIN-2016-01
Acronym: REALITY
Status last verified: Oct 2020
First submitted: 26 Jul 2016
Last updated: 19 Oct 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 16908785
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.
PubMed 17489079
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.
PubMed 22147886
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.
PubMed 25147039
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.
PubMed 24402764
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.
PubMed 23703778
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.
PubMed 26106946
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.
PubMed 25472980
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.
PubMed 26476467
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.
PubMed 18272892
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.
PubMed 18779447
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.
PubMed 23192918
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.
PubMed 24456716
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.
PubMed 24806955
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.
PubMed 24402839

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The REALITY Study: DiRectional AthErectomy + Drug-CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions
ClinicalTrials.gov ID: NCT02850107
Acronym / sponsor ID: REALITY / VIVA-CLIN-2016-01
Conditions: Peripheral Vascular Disease
Keywords: Atherectomy, Drug-Coated Balloon
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: VIVA PhysiciansUniversity, hospital or other
Collaborators: Medtronic
Study start: 1 Jun 2016 (actual)
Primary completion: 16 Jun 2020 (actual)
Study completion: 16 Jun 2020 (actual)
First posted: 29 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Non-randomized	Other	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 PlacementDirectional 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

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.

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Non-randomized
Medtronic IN.PACT® Admiral® DCBFDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.	Device	Non-randomized
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	Non-randomized
Volcano Visions® PV .014" IVUS catheterLesion IVUS assessment using the Volcano Visions® PV .014" IVUS catheter will be required in all cases.	Device	Non-randomized
Nitinol Stent PlacementOnly FDA approved nitinol stents can be used if provisional stenting is required.	Device	Non-randomized

Primary outcome

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.

13 secondary outcomes

Device Success
Time frame: Post Index Procedure
Procedural Success
Time frame: Post Index Procedure
IVUS
Time frame: Post Index Procedure
PACCS scoring and related procedural complications
Time frame: 1 month
Directional Atherectomy
Time frame: Post Index Procedure
Major Adverse Events thru 24 months
Time frame: 24 months
Post procedure TVR
Time frame: 6, 12, 24 months
CD-TLR post procedure
Time frame: 6, 12, 24 months
Time to CD-TLR thru 24 months post procedure
Time frame: 24 months
Major target limb amputation post procedure
Time frame: 6, 12, 24 months
Thrombosis- target lesion post procedure
Time frame: 6, 12, 24 months
Primary sustained clinical improvement
Time frame: 6, 12, 24 months
Secondary sustained clinical improvement
Time frame: 6, 12, 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Results publication: PubMed 16908785Golomb 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.
Results publication: PubMed 17489079Norgren 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.
Results publication: PubMed 22147886Goodney 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.
Results publication: PubMed 25147039McKinsey 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.
Results publication: PubMed 24402764Roberts 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.
Results publication: PubMed 23703778Yazdani 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.
Results publication: PubMed 26106946Rosenfield 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.
Results publication: PubMed 25472980Tepe 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.
Results publication: PubMed 26476467Laird 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.
Results publication: PubMed 18272892Tepe 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.
Results publication: PubMed 18779447Werk 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.
Results publication: PubMed 23192918Werk 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.
HawkOne 510(k) clearance.Link provided by the sponsor.
Turbo Hawk 3 510(k) clearances.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Krishna Singh, MD principal investigator

VIVA Physicians, Inc.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Patency (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02850107, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.