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Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries (LEVANT 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01412541
First received: August 5, 2011
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard PTA catheter for treatment of stenosis of the femoropopliteal arteries.


Condition Intervention Phase
Femoral Arterial Stenosis
Stenosis of Popliteal Arteries
Femoral Artery Occlusion
Occlusion of Popliteal Arteries
Procedure: Standard Uncoated Angioplasty Balloon
Device: Moxy Drug Coated Balloon
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Composite of freedom from all-cause peri-operative (≤30 day) death and freedom from the following: index limb amputation, index limb re-intervention, and index-limb-related death. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Primary Patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Freedom from all-cause death, index limb amputation above the ankle and TVR (VIVA Safety Endpoint)

  • Primary and Secondary Patency (DUS PSVR <2.5) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Efficacy

  • Safety [ Time Frame: 1, 6, 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, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death.

  • Alternative Primary and Secondary Patency based on alternative definitions of DUS PSVR <2.0 and <3.0 [ Time Frame: 6, 12 and 24 Months ] [ Designated as safety issue: No ]
    Efficacy

  • DUS Clinical Patency (DUS PSVR <2.5 without prior Clinically Driven TLR) [ Time Frame: 6, 12 and 24 Months ] [ Designated as safety issue: No ]
    Efficacy

  • Target Lesion Revascularization (TLR) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Efficacy: Clinically Driven and Total (Clinical and DUS/angiography-driven)

  • Change of Rutherford classification from baseline [ Time Frame: 6, 12 and 24 Months ] [ Designated as safety issue: No ]
    Efficacy

  • Change of resting ABI from baseline [ Time Frame: 6, 12 and 24 Months ] [ Designated as safety issue: No ]
    Efficacy

  • Change in Walking Impairment Questionnaire from baseline [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Efficacy

  • Change in Six Minute Walk Test from baseline in a subset of patients [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Efficacy

  • Change in quality of life from baseline, as measured by EQ-5D and SF36-v2 surveys [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Efficacy

  • All-cause death [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
  • Amputation (above the ankle)-Free Survival (AFS) [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
  • Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
  • Major vascular complications [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
  • Readmission for cardiovascular events [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Target limb related hospital days [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]

Enrollment: 476
Study Start Date: July 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxy Drug Coated Balloon
Paclitaxel coated balloon catheter
Device: Moxy Drug Coated Balloon
Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon
Active Comparator: Standard Uncoated Balloon Angioplasty Catheter
PTA Catheter
Procedure: Standard Uncoated Angioplasty Balloon
Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon

Detailed Description:

The Moxy Drug Coated Balloon is indicated for percutaneous transluminal angioplasty of obstructive de novo or non-stented restenotic lesions in native femoropopliteal arteries up to 15 cm in length and ≥4.0 to ≤6.0 mm in diameter. This study will randomize approximately 476 patients who will receive either the Moxy balloon or standard balloon angioplasty at 55 global investigational sites. Subjects will be blinded to treatment until 12 months and will participate in long term follow-up for 5 years.

  Eligibility

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

Inclusion Clinical 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 Criteria Lesion 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

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: NCT01412541

  Show 54 Study Locations
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
Principal Investigator: Prof. Dierk Scheinert, MD Park Krankenhaus
  More Information

Additional Information:
No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01412541     History of Changes
Other Study ID Numbers: CL0002-01
Study First Received: August 5, 2011
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Arms
Experimental
Drug Coated Angioplasty Balloon
Active Comparator
Standard angioplasty balloon

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2014