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

NCT ID: NCT01412541

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2018-12-31

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.

Detailed Description

The Moxy Drug Coated Balloon is indicated for percutaneous transluminal angioplasty of obstructive de novo or non-stented restenotic lesions in native femoropopliteal arteries up to 15 cm in length and ≥4.0 to ≤6.0 mm in diameter. This study will randomize approximately 476 patients who will receive either the Moxy balloon or standard balloon angioplasty at 55 global investigational sites. Subjects will be blinded to treatment until 12 months and will participate in long term follow-up for 5 years.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Moxy Drug Coated Balloon

Paclitaxel coated balloon catheter

Group Type: EXPERIMENTAL

Moxy Drug Coated Balloon

Intervention Type: DEVICE

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

Standard Uncoated Angioplasty Balloon

PTA Catheter

Group Type: ACTIVE_COMPARATOR

Standard Uncoated Angioplasty Balloon

Intervention Type: PROCEDURE

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

Interventions

Standard Uncoated Angioplasty Balloon

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

Intervention Type: PROCEDURE

Moxy Drug Coated Balloon

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

Intervention Type: DEVICE

Eligibility Criteria

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;

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 myocardial infarction (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 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);

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Rosenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Prof. Dierk Scheinert

Role: PRINCIPAL_INVESTIGATOR

University Leipzig

Locations

Good Samaritan Hospital

Los Angeles, California, United States

North County Radiology Medial Group Inc.

Oceanside, California, United States

St. Joseph's Hospital

Orange, California, United States

University of California Davis

Sacramento, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Washington Cardiology Center

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

Heart and Vascular Institute

Clearwater, Florida, United States

Interventional Cardiolgists of Gainesville

Gainesville, Florida, United States

Munroe Regional Medical Center

Ocala, Florida, United States

Cardiovascular Associates

Elk Grove Village, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Edward Heart

Oakbrook Terrace, Illinois, United States

St. John's Hospital

Springfield, Illinois, United States

Allen County Cardiology

Fort Wayne, Indiana, United States

St. Vincent Heart Center of Indianapolis

Indianapolis, Indiana, United States

Methodist Medical Center

Des Moines, Iowa, United States

Promise Regional Medical Center

Hutchinson, Kansas, United States

St. Francis Heart & Vascular Center

Topeka, Kansas, United States

Massachusetts Genearl Hospital

Boston, Massachusetts, United States

Detroit Medical Center

Detroit, Michigan, United States

St. John's Hospital

Detroit, Michigan, United States

Michigan Heart

Ypsilanti, Michigan, United States

Mercy Hosptial

Coon Rapids, Minnesota, United States

Forrest General Hospital

Hattiesburg, Mississippi, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Our Lady of Lourdes Medical Center

Cherry Hill, New Jersey, United States

New York University Medical Center

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia Universtiy Medical Center

New York, New York, United States

Wake Heart and Vascular

Raleigh, North Carolina, United States

Christ Hospital / The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Mid Ohio Cardiology and Vascular Consultants

Columbus, Ohio, United States

Jobst Vascular Institute

Toledo, Ohio, United States

Univesrity of Toledo Medical Center

Toledo, Ohio, United States

Greenville Memorial Hospital

Greenville, South Carolina, United States

Wellmont Cardiology Services

Kingsport, Tennessee, United States

East Tennessee Heart Consultants

Knoxville, Tennessee, United States

Baptist DeSoto in Southaven

Memphis, Tennessee, United States

Austin Heart P.A.

Austin, Texas, United States

Medical University of Graz

Graz, , Austria

Medical University of Vienna

Vienna, , Austria

Imelda Ziekenhuis

Bonheiden, , Belgium

Flanders Medical Research Program

Dendermonde, , Belgium

Herz-Zentrum

Bad Krozingen, , Germany

Jewish Hospital

Berlin, , Germany

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Diakonissenanstalt zu Flensburg

Flensburg, , Germany

Hamburg University Cardiovascular Center

Hamburg, , Germany

University Leipzig

Leipzig, , Germany

University Magdeburg

Magdeburg, , Germany

University of Tübingen

Tübingen, , Germany

Countries

United States; Austria; Belgium; Germany

References

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.

Reference Type: DERIVED

PMID: 31575518 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27117972 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26106946 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CL0002-01

Identifier Type: -

Identifier Source: org_study_id