IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA (NCT02963649) | Clinical Trial Compass
CompletedNot Applicable
IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
Belgium, France, Greece50 participantsStarted 2017-03-02
Plain-language summary
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
✓. Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation.
✓. Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5.
✓. Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.
✓. Life expectancy \>1 year in the Investigator's opinion.
✓. Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.
✓. Total occlusions with total lesion length ≥ 40 mm (by visual estimate).
Exclusion criteria
✕. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
✕. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
✕. Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
✕
What they're measuring
1
Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months
. Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
✕. Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
✕. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
✕. Previous DCB procedure in the target vessel within 6 months prior to index procedure.