Overview

This trial is active, not recruiting.

Conditions femoral artery stenosis, popliteal artery stenosis, femoral artery occlusion, popliteal artery occlusion
Treatments standard uncoated angioplasty balloon, moxy drug coated balloon
Sponsor C. R. Bard
Start date July 2011
End date November 2013
Trial size 476 participants
Trial identifier NCT01412541, CL0002-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Paclitaxel coated balloon catheter
moxy drug coated balloon
Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon
(Active Comparator)
PTA Catheter
standard uncoated angioplasty balloon
Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon

Primary Outcomes

Measure
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
Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year.
time frame: 12 months

Secondary Outcomes

Measure
Secondary Efficacy #1 - Number of Devices With Device Success.
time frame: During the procedure
Secondary Efficacy #1A - Number of Subjects With Technical Success.
time frame: During the procedure
Secondary Efficacy #1B - Number of Subjects With Procedural Success.
time frame: During the 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
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
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
Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency Rate at 12 Months (Defined by Core Lab Adjudication).
time frame: 12 Months
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
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
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
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
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
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
Secondary Efficacy #5 - Percentage of Subject With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6 Months.
time frame: 6 Months
Secondary Efficacy #5 - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 12 Months.
time frame: 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
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
Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 6 Months (%Improved).
time frame: Baseline and 6 Months
Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 12 Months.
time frame: Baseline and 12 Months
Secondary Efficacy #7 - Mean Difference Between the Baseline and 6 Months of Resting Ankle Brachial Index (ABI).
time frame: Baseline and 6 Months
Secondary Efficacy #7 - Mean Difference Between the Baseline and 12 Months of Resting Ankle Brachial Index (ABI).
time frame: Baseline and 12 Months
Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 6 Months.
time frame: Baseline and 6 months
Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 12 Months.
time frame: Baseline and 12 Months
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
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
Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 6 Months.
time frame: Baseline and 6 Months
Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 12 Months.
time frame: Baseline and 12 Months
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
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
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
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
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
Secondary Safety #3 - Percentage of Subjects With All-cause Death at 1 Month.
time frame: 1 month
Secondary Safety #3 - Percentage of Subjects With All-cause Death at 6 Months.
time frame: 6 Months
Secondary Safety #3 - Percentage of Subjects With All-cause Death at 12 Months.
time frame: 12 Months
Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 1 Month.
time frame: 1 Month
Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 6 Months.
time frame: 6 Months
Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 12 Months.
time frame: 12 Months
Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 1 Month.
time frame: 1 Month
Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 6 Months.
time frame: 6 Months
Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 12 Months.
time frame: 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
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
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
Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 1 Month.
time frame: 1 Month
Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 6 Months.
time frame: 6 Months
Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 12 Months.
time frame: 12 Months
Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 1 Month.
time frame: 1 Month
Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 6 Months.
time frame: 6 Months
Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 12 Months.
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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.).

Additional Information

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
Principal investigator Kenneth Rosenfield, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.