Status:
COMPLETED
ILLUMENATE Pivotal Post-Approval Study (PAS)
Lead Sponsor:
Spectranetics Corporation
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal...
Detailed Description
The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB. Each enrolled subject will be followed fo...
Eligibility Criteria
Inclusion
- Inclusion Criteria - From ILLUMENATE Pivotal IDE population TP-1397E
- Study subjects must fulfill the following clinical criteria:
- Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery.
- Greater than or equal to 18 years of age.
- Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows.
- Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
- Life expectancy \>1 year.
- Rutherford-Becker classification of 2, 3 or 4.
- Study Subjects must fulfill the following angiographic criteria:
- De novo or restenotic lesion (except for in-stent restenotic lesion) \>70% within the SFA and/or popliteal artery in a single limb.
- Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm.
- Lesion is treatable by no more than two (2) study devices.
- Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.
- Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation).
- Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis \<30% without death or major vascular complication.
- Target limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior magnetic resonance (MR) angiography or computed tomography (CT) angiography (within 45 days prior to index procedure). NOTE: treatment of outflow disease is NOT permitted.
- Exclusion Criteria -
- Subject with any of the following clinical criteria should be excluded:
- Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.
- Known aortic aneurysm(s) \> 5 cm.
- Contraindication to dual anti-platelet therapy.
- Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
- Current participation in an investigational drug or another device study.
- History of hemorrhagic stroke within 3 months.
- Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
- Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion.
- Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.
- Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.
- Chronic renal insufficiency (dialysis dependent, or serum creatinine \>2.5 mg/dL within 30 days of index procedure).
- Subject with any of the following angiographic criteria should be excluded:
- Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.
- No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.
- Known inadequate distal outflow.
- Acute or sub-acute thrombus in the target vessel.
- Aneurysmal target vessel.
- Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.
- Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment).
- Presence of concentric calcification that precludes PTA pre-dilation.
- Prior stent placement in the target vessel.
- Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.
Exclusion
Key Trial Info
Start Date :
June 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03421561
Start Date
June 18 2013
End Date
October 6 2020
Last Update
February 2 2024
Active Locations (41)
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1
Yuma Regional Medical Center
Yuma, Arizona, United States, 85364
2
Mission Cardiovascular Research Institute
Fremont, California, United States, 94538
3
Good Samaritan Hospital - Los Angeles
Los Angeles, California, United States, 90017
4
Medical Center of the Rockies
Loveland, Colorado, United States, 80538