LEVANT 2 Continued Access Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01628159
First received: June 19, 2012
Last updated: March 10, 2015
Last verified: March 2015
  Purpose

The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.


Condition Intervention
Peripheral Artery Disease
Device: Lutonix Drug Coated Balloon

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Unanticipated device- or drug- related adverse events [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
    • Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death
    • Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR) (VIVA Safety Endpoint)

  • Efficacy [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Acute device, technical and procedural success


Enrollment: 675
Study Start Date: June 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lutonix Drug Coated Balloon
Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter
Device: Lutonix Drug Coated Balloon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Clinical Inclusion Criteria:

  1. Male or non-pregnant female ≥18 years of age;
  2. Rutherford Clinical Category 2-4;
  3. Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;

    Angiographic Lesion Inclusion Criteria:

  4. Length ≤15 cm;
  5. Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of <15 cm);
  6. ≥70% stenosis by visual estimate;
  7. 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 TP trunk;
  8. de novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
  9. Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
  10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
  11. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
  12. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
  13. 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);
  14. Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;
  15. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

  1. Pregnant or planning on becoming pregnant or men intending to father children;
  2. Life expectancy of <5 years;
  3. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
  4. History of hemorrhagic stroke within 3 months;
  5. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
  6. History of MI, thrombolysis or angina within 2 weeks of enrollment;
  7. Rutherford Class 0, 1, 5 or 6;
  8. Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
  9. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
  10. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
  11. Anticipated use of IIb/IIIa inhibitor prior to randomization;
  12. Ipsilateral retrograde access;
  13. Composite lesion length is >15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
  14. Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
  15. Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
  16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
  17. Severe calcification that renders the lesion un-dilatable;
  18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628159

  Show 65 Study Locations
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
Principal Investigator: Prof. Dierk Scheinert, MD University Leipzig
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01628159     History of Changes
Other Study ID Numbers: CL0002-09
Study First Received: June 19, 2012
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 29, 2015