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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278991
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

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.

Condition or disease Intervention/treatment
Peripheral Artery Disease Device: Lutonix Drug Coated Balloon

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).

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Study Type : Observational
Actual Enrollment : 149 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Single-Arm, Post-Market Study Using the Lutonix Drug Coated Balloon for Post-Dilatation of the Bard LifeStent Vascular Stent for Treatment of Long Lesions in Femoropopliteal Arteries
Actual Study Start Date : October 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2, 2018

Group/Cohort Intervention/treatment
Lutonix Drug Coated Balloon
Paclitaxel coated balloon catheter
Device: Lutonix Drug Coated Balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon




Primary Outcome Measures :
  1. Primary patency at 12 months. [ Time Frame: 12 months ]
    Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.

  2. Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days. [ Time Frame: 30 days ]
    Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.


Secondary Outcome Measures :
  1. Procedural success [ Time Frame: Immediately after Intervention ]
    Defined as attainment of ≤30% residual stenosis by quantitative angiography immediately after intervention in the absence of peri-procedural complications.

  2. Technical success [ Time Frame: Immediately after intervention ]
    Defined as attainment of ≤30% residual stenosis by quantitative angiography.

  3. Device success [ Time Frame: Immediately after intervention ]
    Defined as successful delivery of the DCB to the target lesion and performance when used according to the clinical investigational plan.

  4. Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure. [ Time Frame: 30 days, 6, 12 and 24 months ]
    Absence of Target Lesion Revascularization.

  5. Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure. [ Time Frame: 30 days, 6, 12 and 24 months ]
    Absence of Target Vessel Revascularization.

  6. Change in resting ankle brachial index (ABI) from baseline to 30 days, and 6, 12 and 24 months post-index procedure [ Time Frame: 30 days, 6, 12 and 24 months ]
    The ABI values will be recorded and compared to the baseline values. The ABI is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. A ratio of 0.9-1.3 is in the normal range. Lower ratios indicate bad blood perfusion of the leg.

  7. Change in Rutherford Classification from baseline to 30 days, and 6, 12 and 24 months post-index procedure [ Time Frame: 30 days, 6, 12 and 24 months ]
    Patients are enrolled with a Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).

  8. All-cause death [ Time Frame: 30 days, 6, 12 and 24 months ]
    Death by any cause will be counted.

  9. Amputation (above the ankle)-free survival [ Time Frame: 30 days, 6, 12 and 24 months ]
    Amputations above the ankle of the target leg will be counted.

  10. Target limb reintervention for treatment of thrombosis of target vessel or embolization to its distal vasculature [ Time Frame: 30 days, 6, 12 and 24 months ]
    Thrombosis in the target vessel and embolizations below the target lesion will be analazed separately from other stenoses.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital Patients
Criteria

Inclusion Criteria: Subjects will be included if all of the following inclusion criteria apply:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278991


Locations
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Germany
Klinikum Arnsberg
Arnsberg, Germany, 59755
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, Germany, 29549
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany, 79189
Angiologikum Hamburg
Hamburg, Germany, 22527
Klinik Immenstadt
Immenstadt, Germany, 87509
Klinikum Kassel
Kassel, Germany, 34125
UKSH - Campus Lübeck
Lübeck, Germany, 23538
RoMed Klinikum Rosenheim
Rosenheim, Germany, 83022
Gefäßzentrum Sonneberg
Sonneberg, Germany, 96515
Klinikum Weiden
Weiden, Germany, 92637
Greece
University General Hospital of Patras
Patras, Greece, 26504
Poland
SPZOZ Sanok
Sanok, Poland, 38-500
Sponsors and Collaborators
C. R. Bard
Investigators
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Principal Investigator: Thomas Zeller, Prof.

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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02278991    
Other Study ID Numbers: CL0022-01
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases