Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries

NCT01412541 | Completed Results DMC

• 1 other identifier: CL0002-01
• Study Type: interventional
• Target: 532
• Locations: 4 countries
• Sites: 54

Brief Summary

The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.

Conditions

Femoral Artery Stenosis; Popliteal Artery Stenosis; Femoral Artery Occlusion; Popliteal Artery Occlusion

Keywords

Arms; Experimental; Drug Coated Angioplasty Balloon; Active Comparator; Standard Angioplasty Balloon

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure

  Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.

  12 months post index procedure

• Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure

  Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).

  12 months post index procedure

Secondary Outcomes (16)

• Number of Acute Device Success at Time of Index Procedure

  At time of Index Procedure

• Number of Participants With Technical and Procedural Success

  At time of Index Procedure

• Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure

  6, 12, and 24 months post index procedure

• Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure

  6, 12, and 24 months post index procedure

• Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure

  6, 12, and 24 months post index porcedure

Study Arms (2)

Moxy Drug Coated Balloon

EXPERIMENTAL

Paclitaxel coated balloon catheter

Device: Moxy Drug Coated Balloon

Standard Uncoated Angioplasty Balloon

ACTIVE COMPARATOR

PTA Catheter

Procedure: Standard Uncoated Angioplasty Balloon

Interventions

Standard Uncoated Angioplasty Balloon PROCEDURE

Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon

Standard Uncoated Angioplasty Balloon

Moxy Drug Coated Balloon DEVICE

Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon

Moxy Drug Coated Balloon

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant female ≥18 years of age;
• Rutherford Clinical Category 2-4;
• Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;
• Length ≤15 cm;
• 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);
• ≥70% stenosis by visual estimate;
• 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;
• de novo lesion(s) or non-stented restenotic lesion(s) \>90 days from prior angioplasty procedure;
• Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
• Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
• Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
• 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.
• 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);
• 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;
• No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• Pregnant or planning on becoming pregnant or men intending to father children;
• Life expectancy of \<5 years;
• 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.
• History of hemorrhagic stroke within 3 months;
• Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
• History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of enrollment;
• Rutherford Class 0, 1, 5 or 6;
• Renal failure or chronic kidney disease with modification in diet in renal disease glomerular filtration rate (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);
• 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;
• Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
• Anticipated use of IIb/IIIa inhibitor prior to randomization;
• Ipsilateral retrograde access;
• Composite lesion length is \>15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
• Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (54)

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

North County Radiology Medial Group Inc.

Oceanside, California, 92056, United States

Location

St. Joseph's Hospital

Orange, California, 92868, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Washington Cardiology Center

Washington D.C., District of Columbia, 20010, United States

Location

Heart and Vascular Institute

Clearwater, Florida, 33756, United States

Location

Interventional Cardiolgists of Gainesville

Gainesville, Florida, 32605, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Cardiovascular Associates

Elk Grove Village, Illinois, 60007, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Edward Heart

Oakbrook Terrace, Illinois, 60181, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

Allen County Cardiology

Fort Wayne, Indiana, 46802, United States

Location

St. Vincent Heart Center of Indianapolis

Indianapolis, Indiana, 46260, United States

Location

Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Promise Regional Medical Center

Hutchinson, Kansas, 67502, United States

Location

St. Francis Heart & Vascular Center

Topeka, Kansas, 66606, United States

Location

Massachusetts Genearl Hospital

Boston, Massachusetts, 02114, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

St. John's Hospital

Detroit, Michigan, 48236, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Mercy Hosptial

Coon Rapids, Minnesota, 55433, United States

Location

Forrest General Hospital

Hattiesburg, Mississippi, 39401, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Our Lady of Lourdes Medical Center

Cherry Hill, New Jersey, 08034, United States

Location

New York University Medical Center

New York, New York, 10010, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia Universtiy Medical Center

New York, New York, 10032, United States

Location

Wake Heart and Vascular

Raleigh, North Carolina, 27610, United States

Location

Christ Hospital / The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Mid Ohio Cardiology and Vascular Consultants

Columbus, Ohio, 43214, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

Univesrity of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29615, United States

Location

Wellmont Cardiology Services

Kingsport, Tennessee, 37660, United States

Location

East Tennessee Heart Consultants

Knoxville, Tennessee, 37934, United States

Location

Baptist DeSoto in Southaven

Memphis, Tennessee, 38120, United States

Location

Austin Heart P.A.

Austin, Texas, 78705, United States

Location

Medical University of Graz

Graz, A-8036, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

Flanders Medical Research Program

Dendermonde, 9200, Belgium

Location

Herz-Zentrum

Bad Krozingen, 79189, Germany

Location

Jewish Hospital

Berlin, 13347, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Diakonissenanstalt zu Flensburg

Flensburg, 24939, Germany

Location

Hamburg University Cardiovascular Center

Hamburg, 22527, Germany

Location

University Leipzig

Leipzig, 04103, Germany

Location

University Magdeburg

Magdeburg, 39120, Germany

Location

University of Tübingen

Tübingen, 72076, Germany

Location

Related Publications (3)

• 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.

  PMID: 31575518 DERIVED

• Scheinert D, Schmidt A, Zeller T, Muller-Hulsbeck S, Sixt S, Schroder H, Weiss N, Ketelsen D, Ricke J, Steiner S, Rosenfield K. German Center Subanalysis of the LEVANT 2 Global Randomized Study of the Lutonix Drug-Coated Balloon in the Treatment of Femoropopliteal Occlusive Disease. J Endovasc Ther. 2016 Jun;23(3):409-16. doi: 10.1177/1526602816644592. Epub 2016 Apr 26.

  PMID: 27117972 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Rhabdomyosarcoma, Alveolar

Condition Hierarchy (Ancestors)

Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Results Point of Contact

• Title: Anna Lovas
• Organization: Becton Dickinson

anna.lovas@bd.com

7634452382

Study Officials

• Kenneth Rosenfield, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Prof. Dierk Scheinert

  University Leipzig

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All Duplex Ultrasound operators, core lab evaluators, and members of the Clinical Events Committee (CEC) will be blinded to the subject's treatment assignment. Both the subject as well as the Investigator conducting the follow-up visit will be blinded to treatment until the completion of the 12 month visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 9, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2018
• Last Updated: May 12, 2020
• Results First Posted: March 29, 2016

Record last verified: 2020-05

Locations

US (42); BE (2); DE (8); AU (2)