Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Ar… (NCT01412541) | Clinical Trial Compass
CompletedNot Applicable
Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries
United States532 participantsStarted 2011-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or non-pregnant female ≥18 years of age;
✓. Rutherford Clinical Category 2-4;
✓. Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;
✓. Length ≤15 cm;
✓. 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);
✓. ≥70% stenosis by visual estimate;
✓. 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;
✓. de novo lesion(s) or non-stented restenotic lesion(s) \>90 days from prior angioplasty procedure;
Exclusion criteria
✕. Pregnant or planning on becoming pregnant or men intending to father children;
✕. Life expectancy of \<5 years;
✕. 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.
✕. History of hemorrhagic stroke within 3 months;
What they're measuring
1
Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure
Timeframe: 12 months post index procedure
2
Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure
✕. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
✕. History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of enrollment;
✕. Rutherford Class 0, 1, 5 or 6;
✕. 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);