Clinical trial NCT02013271: Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Official title: A Prospective, Multicenter, Single-Arm Trial With the Lutonix Drug Coated Balloon for Treatment of Long Lesions in Femoropopliteal Arteries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Artery Occlusion
Femoral Arterial Stenosis
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

Detailed description: 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).

The primary safety and efficacy endpoint assessments are performed at 12 months. Clinical follow-up continues through a minimum of 2 years and telephone follow-up through a minimum of 3 years.

Eligibility criteria: Inclusion Criteria:

Clinical Criteria

1. ≥ 18 years of age;
2. Rutherford Clinical Category 2-4;
3. 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
4. Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting;
5. TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length;
6. de novo lesion(s) or non-stented restenotic lesion(s) \> 90 days from prior angioplasty procedure;
7. Proximal margin of target lesion(s) starts ≥ 1 cm below the common femoral bifurcation;
8. Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk;
9. Target vessel diameter between ≥ 4 and ≤ 7 mm and able to be treated with available device size matrix;
10. 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.
11. 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.
12. 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);
13. No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment.

Exclusion Criteria:

1. 1. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
2. Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
3. Life expectancy of \< 1year;
4. 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.
5. History of stroke within 3 months;
6. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
7. 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;
8. Target lesion involves a previously placed stent
9. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
10. No normal proximal artery segment in which duplex flow velocity can be measured;
11. Significant inflow disease. Successful treatment of inflow iliac disease allowed prior to target lesion treatment;
12. Unsuccessful crossing; NOTE: crossing devices allowed
13. 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;
14. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel;
15. Intended use of laser, atherectomy or cryoplasty during the index procedure.

Primary outcomes:
measure: Overall Medical Safety
timeFrame: 12 Months
measure: Primary Endpoint Efficacy, measured by presence of primary patency of the target lesion. Patency is assessed by a Corelab based on ultrasound images
timeFrame: 12 Months
Secondary outcomes:
measure: Secondary Endpoint Medical Safety: Major vascular complications
timeFrame: ≤30 days after index procedure
measure: Secondary Endpoint Medical Safety: Composite Safety
timeFrame: 1, 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Medical Safety: All-cause death
timeFrame: 1, 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Medical Safety: Major amputation at target limb
timeFrame: 1, 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Medical Safety: Minor amputation at target limb
timeFrame: 1, 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)
timeFrame: 1, 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Medical Safety: Target Limb Reintervention
timeFrame: 1, 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Efficacy: Acute Device Success
timeFrame: During index procedure
measure: Secondary Endpoint Efficacy: Technical Success
timeFrame: During index procedure
measure: Secondary Endpoint Efficacy: Procedural Success
timeFrame: Until index hospitalization discharge
measure: Secondary Endpoint Efficacy: Primary Patency
timeFrame: 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Efficacy: Secondary Patency
timeFrame: 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)
timeFrame: 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)
timeFrame: 6, 12, 24, 36 months after index procedure
measure: Secondary Endpoint Efficacy: Change of Rutherford classification from baseline
timeFrame: 6, 12, 24 months after index procedure
measure: Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline
timeFrame: 6, 12, 24 months after index procedure
measure: Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline
timeFrame: 6, 12, 24 months after index procedure
measure: Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D
timeFrame: 6, 12, 24 months after index procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Antwerpen
country: Belgium
facility: ZNA-Campus Middelheim
city: Edegem
country: Belgium
facility: UZA Antwerp University Hospital
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Talence cedex
country: France
facility: CHU Bordeaux
city: Berlin
country: Germany
facility: Ev.Krankenhaus Königin Elisabeth
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Heidelberg
country: Germany
facility: University Clinical Center Heidelberg
city: Münster
country: Germany
facility: Westfälische Wilhelms-Universität Münster
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
city: Sonneberg
country: Germany
facility: Medinos Kliniken Sonneberg
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital, Division of Angiology
Study officials:
affiliation: Cantonal Hospital, Lucerne
name: Martin Banyai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Prof. Eric Ducasse, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: