LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)

Peripheral Artery Disease Clinical Trial

Official title:

A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628159
• Other study ID #: CL0002-09
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: December 2018

Study information

• Verified date: March 2020
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Lutonix Drug Coated Balloon
balloon angioplasty with a drug coated balloon

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	Klinikum Klagenfurt	Klagenfurt
Belgium	OLV Ziekenhuis	Aalst
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	Flanders Medical Research Program	Dendermonde
Belgium	Hospital Oost-Limburg	Genk
Belgium	Ghent University Hospital	Ghent
Germany	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 Clinical Center Heidelberg	Heidelberg
Germany	Herz-Und Gefasszentrum	Immenstadt
Germany	Practice for Interventional Radiology	Kaiserslautern
Germany	Westpfalz Clinic	Kusen
Germany	University Leipzig	Leipzig
Germany	University Magdeburg	Magdeburg
Germany	Universtiy Clinic Muenster	Muenster
Germany	University of Munich	Munich
Germany	Ernst von Bergham Clinic	Potstdam
Germany	University of Tübingen	Tübingen
Switzerland	University Hospital	Bern
Switzerland	Canton Hospital Lucerne	Lucerne
Switzerland	University Hospital, Zurich	Zurich
United States	Austin Heart P.A.	Austin	Texas
United States	Massachusetts Genearl Hospital	Boston	Massachusetts
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	Christ Hospital / The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Heart and Vascular Institute	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Mid Ohio Cardiology and Vascular Consultants	Columbus	Ohio
United States	Mercy Hosptial	Coon Rapids	Minnesota
United States	Detroit Medical Center	Detroit	Michigan
United States	St. John's Hospital	Detroit	Michigan
United States	Cardiovascular Associates	Elk Grove Village	Illinois
United States	Allen County Cardiology	Fort Wayne	Indiana
United States	Interventional Cardiolgists of Gainesville	Gainesville	Florida
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Forrest General Hospital	Hattiesburg	Mississippi
United States	Promise Regional Medical Center	Hutchinson	Kansas
United States	St. Vincent Heart Center of Indianapolis	Indianapolis	Indiana
United States	Wellmont Cardiology Services	Kingsport	Tennessee
United States	East Tennessee Heart Consultants	Knoxville	Tennessee
United States	Good Samaritan Hospital	Los Angeles	California
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Columbia Universtiy Medical Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Edward Heart / Midwest Research Foundation	Oakbrook Terrace	Illinois
United States	Munroe Regional Medical Center	Ocala	Florida
United States	North County Radiology Medial Group Inc.	Oceanside	California
United States	St. Joseph's Hospital	Orange	California
United States	Wake Heart and Vascular	Raleigh	North Carolina
United States	University of California Davis	Sacramento	California
United States	St. John's Hosptial	Springfield	Illinois
United States	Jobst Vascular Institute	Toledo	Ohio
United States	Univesrity of Toledo Medical Center	Toledo	Ohio
United States	St. Francis Heart & Vascular Center	Topeka	Kansas
United States	Washington Cardiology Center	Washington	District of Columbia
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure		60 months Post Index Procedure
Secondary	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	Composite of freedom from all-cause perioperative (= 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death.	1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure
Secondary	Number of Acute Device Success at Time of Index Procedure	In certain procedures, more than one device was use resulting in a higher number of devices (894) than participants (657) for this endpoint.	At time of Index Procedure
Secondary	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	This VIVA Safety Endpoint is defined as Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR).	30 days post index procedure
Secondary	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)		1, 6, 12, 24, 36, 48, and 60 months post index procedure
Secondary	Number of Participants With Technical and Procedural Success		At time of index procedure
Secondary	Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure	Primary patency is defined as freedom from target lesion restenosis by core lab adjudication (DUS = 2.5) and target lesion revascularization (TLR).	6, 12, and 24 months post index procedure
Secondary	Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure	Presented is a summary of the Mean change in resting Ankle Brachial Index (ABI) from baseline through 24 months post index procedure. The ABI is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. A lower ABI number suggests more Peripheral Arterial Disease.	6, 12, and 24 months post index procedure
Secondary	Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure		1, 6, 12, and 24 months post index procedure
Secondary	Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure	The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.	6, 12, and 24 months post index procedure
Secondary	Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure	Alternative Primary and Secondary Patency based on alternative definitions of Duplex Ultrasonography (DUS) Peak Systolic Velocity Ratio (PSVR) <2.0 and <3.0; Duplex Ultrasonography (DUS) Clinical Patency (DUS Peak Systolic Velocity Ratio (PSVR) <2.5 without prior Clinically Driven TLR)	6, 12, and 24 months post index procedure