Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries

NCT02013271 | Completed DMC

• 1 other identifier: CL0017-01
• Study Type: observational
• Target: 125
• Locations: 5 countries
• Sites: 14

Brief Summary

To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA

Conditions

Femoral Artery Occlusion; Femoral Arterial Stenosis

Outcome Measures

Primary Outcomes (2)

• Overall Medical Safety

  Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle) and index limb re-intervention. Success is freedom from all specified events; failure is one or more specified events occurs.

  12 Months

• Primary Endpoint Efficacy, measured by presence of primary patency of the target lesion. Patency is assessed by a Corelab based on ultrasound images

  Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis. Binary restenosis is adjudicated by the independent, blinded core laboratory based on threshold Doppler PSVR ≥ 2.5 (together with wafeform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol). Clinically-Driven TLR is adjudicated by the Clincal Events Committee.

  12 Months

Secondary Outcomes (18)

• Secondary Endpoint Medical Safety: Major vascular complications

  ≤30 days after index procedure

• Secondary Endpoint Medical Safety: Composite Safety

  1, 6, 12, 24, 36 months after index procedure

• Secondary Endpoint Medical Safety: All-cause death

  1, 6, 12, 24, 36 months after index procedure

• Secondary Endpoint Medical Safety: Major amputation at target limb

  1, 6, 12, 24, 36 months after index procedure

• Secondary Endpoint Medical Safety: Minor amputation at target limb

  1, 6, 12, 24, 36 months after index procedure

Study Arms (1)

Lutonix DCB

Lutonix Paclitaxel Drug Coated Balloon

Device: Lutonix Paclitaxel Drug Coated Balloon (DCB)

Interventions

Lutonix Paclitaxel Drug Coated Balloon (DCB) DEVICE

Patients exposed to the DCB as part of their routine care.

Lutonix DCB

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

The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm \< RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB).

You may qualify if:

• Clinical Criteria
• ≥ 18 years of age;
• Rutherford Clinical Category 2-4;
• The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF).
• Angiographic Criteria
• Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting;
• TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length;
• de novo lesion(s) or non-stented restenotic lesion(s) \> 90 days from prior angioplasty procedure;
• Proximal margin of target lesion(s) starts ≥ 1 cm below the common femoral bifurcation;
• Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk;
• Target vessel diameter between ≥ 4 and ≤ 7 mm and able to be treated with available device size matrix;
• A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication.
• Successful wire crossing and pre-dilatation of the target lesion; NOTE: Use of crossing devices allowed if necessary NOTE: Bare nitinol stenting of short segments (length minimized to the mechanical defect) is required after pre-dilatation to resolve flow-limiting dissections or if deemed clinically necessary.
• 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);
• No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment.

You may not qualify if:

• \. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
• Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
• Life expectancy of \< 1year;
• Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in an investigational device or pharmaceutical clinical trial during the follow up period is not allowed.
• History of stroke within 3 months;
• History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
• Prior vascular surgery of the index limb, with the exception of endarterectomy or remote common femoral patch angioplasty, separated by at least 1 cm from the target lesion;
• Target lesion involves a previously placed stent
• Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
• No normal proximal artery segment in which duplex flow velocity can be measured;
• Significant inflow disease. Successful treatment of inflow iliac disease allowed prior to target lesion treatment;
• Unsuccessful crossing; NOTE: crossing devices allowed
• Known inadequate distal outflow (\> 50% stenosis of distal popliteal or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
• Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel;
• Intended use of laser, atherectomy or cryoplasty during the index procedure.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (14)

LKH-Univ. Klinikum Graz

Graz, 8036, Austria

Location

ZNA-Campus Middelheim

Antwerp, 2020, Belgium

Location

UZA Antwerp University Hospital

Edegem, 2650, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

CHU Bordeaux

Talence, 33404, France

Location

Ev.Krankenhaus Königin Elisabeth

Berlin, 10365, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

University Clinical Center Heidelberg

Heidelberg, 69120, Germany

Location

Westfälische Wilhelms-Universität Münster

Münster, 48149, Germany

Location

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, 93049, Germany

Location

Medinos Kliniken Sonneberg

Sonneberg, 96515, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Luzerner Kantonsspital, Division of Angiology

Lucerne, 6000, Switzerland

Location

Study Officials

• Martin Banyai, MD, PhD

  Cantonal Hospital, Lucerne

  PRINCIPAL INVESTIGATOR

• Prof. Eric Ducasse, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 17, 2013
• Study Start: December 1, 2013
• Primary Completion: May 23, 2016
• Study Completion: June 13, 2018
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); CH (1); BE (4); AU (1); DE (7)