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

NCT02278991 | Completed

• 1 other identifier: CL0022-01
• Study Type: observational
• Target: 149
• Locations: 3 countries
• Sites: 12

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• Primary patency at 12 months.

  Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.

  12 months

• Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.

  Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.

  30 days

Secondary Outcomes (10)

• Procedural success

  Immediately after Intervention

• Technical success

  Immediately after intervention

• Device success

  Immediately after intervention

• Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure.

  30 days, 6, 12 and 24 months

• Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure.

  30 days, 6, 12 and 24 months

Study Arms (1)

Lutonix Drug Coated Balloon

Paclitaxel coated balloon catheter

Device: Lutonix Drug Coated Balloon

Interventions

Lutonix Drug Coated Balloon DEVICE

Subject will receive treatment with the Lutonix Drug Coated Balloon

Lutonix Drug Coated Balloon

Eligibility Criteria

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

Study Population

Hospital Patients

You may qualify if:

• Age ≥18 years;
• 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);
• Rutherford Category 2-4;
• 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;
• Patients must be able to be treated with Lutonix DCB and LifeStent®;
• Total Lutonix DCB treated segment(s) of 10-24 cm in length;
• Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
• 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®).
• 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;
• Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
• 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.

You may not qualify if:

• Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
• Contraindication to Lutonix DCB or LifeStent® per current IFU;
• Life expectancy of \<1 year;
• 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;
• Intended treatment of outflow disease during the index procedure;
• Intended use of laser, atherectomy or cryoplasty during index procedure;
• Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
• History of stroke within 3 months;
• History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
• 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;
• Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;
• Target vessel and/or lesion involves a previously placed stent.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (12)

Klinikum Arnsberg

Arnsberg, 59755, Germany

Location

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Angiologikum Hamburg

Hamburg, 22527, Germany

Location

Klinik Immenstadt

Immenstadt im Allgäu, 87509, Germany

Location

Klinikum Kassel

Kassel, 34125, Germany

Location

UKSH - Campus Lübeck

Lübeck, 23538, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Gefäßzentrum Sonneberg

Sonneberg, 96515, Germany

Location

Klinikum Weiden

Weiden, 92637, Germany

Location

University General Hospital of Patras

Pátrai, 26504, Greece

Location

SPZOZ Sanok

Sanok, 38-500, Poland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Thomas Zeller, Prof.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: October 2, 2018
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); PL (1); DE (10)