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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 25, 2016
Last verified: February 2016
  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 percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.

Condition Intervention
Femoral Artery Stenosis
Popliteal Artery Stenosis
Femoral Artery Occlusion
Popliteal Artery Occlusion
Procedure: Standard Uncoated Angioplasty Balloon
Device: Moxy Drug Coated Balloon

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:
  • Primary Safety - Percentage of Subjects With 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 at 12 Months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with 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 at 12 months.

  • Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of subjects with Primary patency of the target lesion at one year. Primary patency is defined as freedom from target lesion restenosis (defined by duplex ultrasound core lab adjudication) and target lesion revascularization (TLR).


Secondary Outcome Measures:
  • Secondary Efficacy #1 - Number of Devices With Device Success. [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Number of devices with Device Success defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.

  • Secondary Efficacy #1A - Number of Subjects With Technical Success. [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Number of subjects with Technical Success defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent.

  • Secondary Efficacy #1B - Number of Subjects With Procedural Success. [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Number of subjects with Procedural Success defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure.

  • Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Duplex Ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 6 months

  • Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with duplex ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 12 months

  • Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency (Absence of Target Lesion Restenosis by Core Lab Adjudication) at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Secondary Patency (absence of target lesion restenosis by core lab adjudication) at 6 Months

  • Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency Rate at 12 Months (Defined by Core Lab Adjudication). [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Secondary Patency Rate at 12 Months (defined by core lab adjudication)

  • Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound Peak Systolic Velocity Ratio (DUS PSVR) <2.0 Through 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound peak systolic velocity ratio (DUS PSVR) <2.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.

  • Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.0 Through 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.

  • Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <3.0 Through 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <3.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.

  • Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <3.0 Through 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <3.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.

  • Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Suplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <2.5 Through 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Alternative Primary Patency based on alternative definitions of Suplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <2.5 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.

  • Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.5 Through 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.5 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.

  • Secondary Efficacy #5 - Percentage of Subject With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subject with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 6 Months

  • Secondary Efficacy #5 - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 12 Months

  • Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 6 Months

  • Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 12 Months. [ Time Frame: 12 Month ] [ Designated as safety issue: No ]
    Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 12 Months

  • Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 6 Months (%Improved). [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]

    Percentage of subjects with change of Rutherford classification from baseline to 6 months (%Improved).

    Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain


  • Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 12 Months. [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with change of Rutherford classification from baseline to 12 months Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain

  • Secondary Efficacy #7 - Mean Difference Between the Baseline and 6 Months of Resting Ankle Brachial Index (ABI). [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
    Mean difference between the baseline and 6 months of resting ankle brachial index (ABI).

  • Secondary Efficacy #7 - Mean Difference Between the Baseline and 12 Months of Resting Ankle Brachial Index (ABI). [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    Mean difference between the baseline and 12 months of resting ankle brachial index (ABI).

  • Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 6 Months. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Mean differences between the total Walking Impairment Questionnaire score from baseline to 6 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.

  • Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 12 Months. [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    Mean differences between the total Walking Impairment Questionnaire score from baseline to 12 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.

  • Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline to 6 Months. [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
    Mean of subjects with change in Six Minute Walk Test distance from baseline to 6 months

  • Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline Through 12 Months. [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    Mean of subjects with change in Six Minute Walk Test distance from baseline through 12 months

  • Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 6 Months. [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
    Mean change of the EuorQol (EQ-5D) index from baseline to 6 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.

  • Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 12 Months. [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    Mean change of the EuorQol (EQ-5D) index from baseline to 12 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.

  • Secondary Efficacy #10A - Mean Change in Quality of Life Physical and Mental Component of SF-36 v2 From Baseline to 6 Months. [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
    Mean change in quality of life physical and mental component of SF-36 v2 from baseline to 6 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).

  • Secondary Efficacy #10A - Mean Change in Quality of Life Physical Component and Mental Component of SF-36 v2 From Baseline to 12 Months. [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    Mean change in quality of life physical component and mental component of SF-36 v2 from baseline to 12 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).

  • Secondary Safety #1 - Percentage of Subjects With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint)

  • Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 1 Month: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 1 Month. [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 1 Month: index limb amputation, index limb re-intervention, and index-limb-related death at 1 month.

  • Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 6 Months: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 6 months: index limb amputation, index limb re-intervention, and index-limb-related death.

  • Secondary Safety #3 - Percentage of Subjects With All-cause Death at 1 Month. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Percentage of subjects with All-cause death at 1 Month

  • Secondary Safety #3 - Percentage of Subjects With All-cause Death at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with All-cause death at 6 Months

  • Secondary Safety #3 - Percentage of Subjects With All-cause Death at 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with All-cause death at 12 Months

  • Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 1 Month. [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 1 Month

  • Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 6 Months

  • Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 12 Months

  • Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 1 Month. [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Target Vessel Revascularization (TVR) at 1 Month

  • Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Target Vessel Revascularization (TVR) at 6 Months

  • Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Target Vessel Revascularization (TVR) at 12 Months

  • Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1 Month. [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 1 Month

  • Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 6 Months

  • Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 12 Months

  • Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 1 Month. [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Major vascular complications at 1 Month

  • Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Major vascular complications at 6 Months

  • Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Major vascular complications at 12 Months

  • Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 1 Month. [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Readmission for cardiovascular events at 1 Month

  • Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 6 Months. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Readmission for cardiovascular events at 6 Months

  • Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 12 Months. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Readmission for cardiovascular events at 12 Months


Other Outcome Measures:
  • Sectondary Safety #9 [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
    Percentage of subjects with Target limb related hospital days


Enrollment: 476
Study Start Date: July 2011
Estimated Study Completion Date: September 2017
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 Angioplasty Balloon
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   (Adult, Senior)
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 myocardial infarction (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 modification in diet in renal disease glomerular filtration rate (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 University Leipzig
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01412541     History of Changes
Other Study ID Numbers: CL0002-01 
Study First Received: August 5, 2011
Results First Received: July 14, 2015
Last Updated: March 25, 2016
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
Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 06, 2016