Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries

NCT ID: NCT02278991

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-10-02

Brief Summary

Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.

Detailed Description

The study will observe subjects presenting with claudication or ischemic rest pain (Rutherford category 2-4) and long (10-24 cm in length) native lesions in the infra-inguinal segment (superficial femoral artery [SFA] and/or proximal popliteal artery) who are candidates for stenting and pre-/post-dilatation with Drug Coated Balloon (DCB).

Conditions

Peripheral Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lutonix Drug Coated Balloon

Paclitaxel coated balloon catheter

Lutonix Drug Coated Balloon

Intervention Type: DEVICE

Subject will receive treatment with the Lutonix Drug Coated Balloon

Interventions

Lutonix Drug Coated Balloon

Subject will receive treatment with the Lutonix Drug Coated Balloon

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years;

2. The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);

3. Rutherford Category 2-4;

4. Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of ≥50% stenosis or occlusion (by visual estimate) and is amenable to treatment with LifeStent® and Lutonix DCB;

5. Patients must be able to be treated with Lutonix DCB and LifeStent®;

6. Total Lutonix DCB treated segment(s) of 10-24 cm in length;

7. Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;

8. At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with LifeStent®).

9. No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;

10. Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;

11. 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 tibioperoneal trunk.

Exclusion Criteria

1. Pregnant, lactating, or planning on becoming pregnant or men intending to father children;

2. Contraindication to Lutonix DCB or LifeStent® per current IFU;

3. Life expectancy of <1 year;

4. Inability to take required antiplatelet/anticoagulant medications per the LifeStent® and Lutonix DCB IFU, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;

5. Intended treatment of outflow disease during the index procedure;

6. Intended use of laser, atherectomy or cryoplasty during index procedure;

7. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;

8. History of stroke within 3 months;

9. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;

10. Participation in an investigational drug or another investigational device study until this study's (Lutonix LifeStent® Study) primary endpoint is reached or previous enrollment in this study;

11. Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;

12. Target vessel and/or lesion involves a previously placed stent.

• 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

Thomas Zeller, Prof.

Role: PRINCIPAL_INVESTIGATOR

Locations

Klinikum Arnsberg

Arnsberg, , Germany

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, , Germany

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, , Germany

Angiologikum Hamburg

Hamburg, , Germany

Klinik Immenstadt

Immenstadt im Allgäu, , Germany

Klinikum Kassel

Kassel, , Germany

UKSH - Campus Lübeck

Lübeck, , Germany

RoMed Klinikum Rosenheim

Rosenheim, , Germany

Gefäßzentrum Sonneberg

Sonneberg, , Germany

Klinikum Weiden

Weiden, , Germany

University General Hospital of Patras

Pátrai, , Greece

SPZOZ Sanok

Sanok, , Poland

Countries

Germany; Greece; Poland

Other Identifiers

CL0022-01

Identifier Type: -

Identifier Source: org_study_id