STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR) (NCT01927068) | Clinical Trial Compass
CompletedNot Applicable
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Australia499 participantsStarted 2013-07
Plain-language summary
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries.
Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.
Who can participate
Age range18 Years – 85 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
✓. Has symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.
✓. Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2 subjects should be entered into the study if conservative treatment has been unsuccessful.
✓. Is ≥18 years old.
✓. Has life expectancy \>1 year.
✓. Is able and willing to provide written informed consent prior to study specific procedures.
✓. Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen.
✓. Has evidence at the target lesion(s) of clinically and hemodynamically significant de novo stenosis or restenosis, or occlusion, in the SFA (1 cm distal to the ostium of the profunda) and/or popliteal artery (proximal to the popliteal trifurcation), confirmed by angiography.
✓. Has target limb with at least one patent (\<50% stenosis) tibio-peroneal run-off vessel to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or computed tomography angiography (CTA). Note: Treatment of outflow disease is NOT permitted.
Exclusion criteria
✕. A female who is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing; or a male intending to father children during the study.
✕. Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
What they're measuring
1
Percentage of Participants With Freedom From Device and Procedure-related Death and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
✕. Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
✕. Is currently participating in another investigational device or drug study that would interfere with study endpoints.
✕. Has history of hemorrhagic stroke within 3 months.
✕. Has surgical or endovascular procedure of the target limb within 14 days prior to the index procedure.
✕. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
✕. Has had a previous peripheral bypass affecting the target limb.