Clinical trial NCT01628159: LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
Official title: A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.

Detailed description: The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries through 5 years.

Eligibility criteria: Clinical Inclusion Criteria:

1. Male or non-pregnant female ≥18 years of age;
2. Rutherford Clinical Category 2-4;
3. Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;

   Angiographic Lesion Inclusion Criteria:
4. Length ≤15 cm;
5. Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of \<15 cm);
6. ≥70% stenosis by visual estimate;
7. Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
8. de novo lesion(s) or non-stented restenotic lesion(s) \>90 days from prior angioplasty procedure;
9. Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
11. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
12. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
13. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);
14. Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;
15. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

1. Pregnant or planning on becoming pregnant or men intending to father children;
2. Life expectancy of \<5 years;
3. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
4. History of hemorrhagic stroke within 3 months;
5. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
6. History of MI, thrombolysis or angina within 2 weeks of enrollment;
7. Rutherford Class 0, 1, 5 or 6;
8. Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
9. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
10. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
11. Anticipated use of IIb/IIIa inhibitor prior to randomization;
12. Ipsilateral retrograde access;
13. Composite lesion length is \>15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
14. Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
15. Known inadequate distal outflow (\>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
17. Severe calcification that renders the lesion un-dilatable;
18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).

Primary outcomes:
measure: Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure
timeFrame: 60 months Post Index Procedure
Secondary outcomes:
measure: Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure
timeFrame: 1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure
measure: Number of Acute Device Success at Time of Index Procedure
timeFrame: At time of Index Procedure
measure: Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure
timeFrame: 30 days post index procedure
measure: Number of Participants With Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure (PPI)
timeFrame: 1, 6, 12, 24, 36, 48, and 60 months post index procedure
measure: Number of Participants With Technical and Procedural Success
timeFrame: At time of index procedure
measure: Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure
timeFrame: 6, 12, and 24 months post index procedure
measure: Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure
timeFrame: 6, 12, and 24 months post index procedure
measure: Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure
timeFrame: 1, 6, 12, and 24 months post index procedure
measure: Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure
timeFrame: 6, 12, and 24 months post index procedure
measure: Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure
timeFrame: 6, 12, and 24 months post index procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Oceanside
country: United States
facility: North County Radiology Medial Group Inc.
state: California
city: Orange
country: United States
facility: St. Joseph's Hospital
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Cardiology Center
state: District of Columbia
city: Clearwater
country: United States
facility: Heart and Vascular Institute
state: Florida
city: Gainesville
country: United States
facility: Interventional Cardiolgists of Gainesville
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Elk Grove Village
country: United States
facility: Cardiovascular Associates
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Edward Heart / Midwest Research Foundation
state: Illinois
city: Springfield
country: United States
facility: St. John's Hosptial
state: Illinois
city: Fort Wayne
country: United States
facility: Allen County Cardiology
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indianapolis
state: Indiana
city: Hutchinson
country: United States
facility: Promise Regional Medical Center
state: Kansas
city: Topeka
country: United States
facility: St. Francis Heart & Vascular Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts Genearl Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Detroit
country: United States
facility: St. John's Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hosptial
state: Minnesota
city: Hattiesburg
country: United States
facility: Forrest General Hospital
state: Mississippi
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Cherry Hill
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia Universtiy Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Heart and Vascular
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital / The Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Cardiology and Vascular Consultants
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Toledo
country: United States
facility: Univesrity of Toledo Medical Center
state: Ohio
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont Cardiology Services
state: Tennessee
city: Knoxville
country: United States
facility: East Tennessee Heart Consultants
state: Tennessee
city: Austin
country: United States
facility: Austin Heart P.A.
state: Texas
city: Graz
country: Austria
facility: Medical University of Graz
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Dendermonde
country: Belgium
facility: Flanders Medical Research Program
city: Genk
country: Belgium
facility: Hospital Oost-Limburg
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum
city: Berlin
country: Germany
facility: Jewish Hospital
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Flensburg
country: Germany
facility: Diakonissenanstalt zu Flensburg
city: Hamburg
country: Germany
facility: Hamburg University Cardiovascular Center
city: Heidelberg
country: Germany
facility: University Clinical Center Heidelberg
city: Immenstadt
country: Germany
facility: Herz-Und Gefasszentrum
city: Kaiserslautern
country: Germany
facility: Practice for Interventional Radiology
city: Kusen
country: Germany
facility: Westpfalz Clinic
city: Leipzig
country: Germany
facility: University Leipzig
city: Magdeburg
country: Germany
facility: University Magdeburg
city: Muenster
country: Germany
facility: Universtiy Clinic Muenster
city: Munich
country: Germany
facility: University of Munich
city: Potstdam
country: Germany
facility: Ernst von Bergham Clinic
city: Tübingen
country: Germany
facility: University of Tübingen
city: Bern
country: Switzerland
facility: University Hospital
city: Lucerne
country: Switzerland
facility: Canton Hospital Lucerne
city: Zurich
country: Switzerland
facility: University Hospital, Zurich
Study officials:
affiliation: Massachusetts General Hospital
name: Kenneth Rosenfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Leipzig
name: Prof. Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ouriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28.