Status:
ACTIVE_NOT_RECRUITING
TORUS 2 IDE Clinical Study
Lead Sponsor:
Endologix
Collaborating Sponsors:
Syntactx
PQ Bypass, Inc.
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the nativ...
Eligibility Criteria
Inclusion
- Patient is male or female, with age \> 18 and ≤ 90 years at date of enrollment.
- Patient provides written informed consent before any study-specific investigations or procedures.
- Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
- Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
- Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery.
- Patient has PAD classified as Rutherford classification 2, 3 or 4.
- Patient has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤ 0.90 (or ≤ 0.75 after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to reliably assess ABI. TBI must be \<0.70; or (ii) Normal ABI with angiographic, ultrasound, MRA, or CT evidence of ≥ 60% diameter stenosis.
- Patient has single or multiple stenotic, restenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
- Single target lesion must be covered by a single stent. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and \> 30% diameter stenosis between the lesion(s).
- Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur.
- Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate.
- Target lesion measures ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and \> 30% diameter stenosis between the lesion(s).
- Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment.
- Patient has at least one patent infrapopliteal vessel (\< 50% stenosis) with run-off to the ankle.
Exclusion
- Patient is unable or is unwilling to comply with the procedural requirements of the study protocol or will have difficulty in complying with the requirements for attending follow-up visits.
- Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
- Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
- Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
- Patient has a target vessel that has been treated with bypass surgery.
- Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.
- Patient has known or suspected active systemic infection at the time of enrollment.
- Patient has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR (international normalized ratio) \>1.8.
- Patient has a stroke diagnosis within three months prior to enrollment.
- Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
- Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
- Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.
- Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).
- Patient has received thrombolysis within 72 hours prior to the index procedure.
- Patient has acute or chronic renal disease (e.g., as measured by a serum creatinine of \> 2.5 mg/dL or \> 220 μmol/L or GFR \< 30 ml/min), or on peritoneal or hemodialysis.
- Patient requiring coronary intervention within seven days prior to enrollment.
- Patient is pregnant or breast-feeding.
- Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device).
- Patient has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
- Patient has significant disease or obstruction (≥ 50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤ 30% residual stenosis, without complication).
- Patient has no patent (≥ 50% stenosis) outflow vessel providing run-off to the ankle.
- There is a lack of full expansion in the predilatation balloon.
- Evidence of aneurysm or acute thrombus in target vessel.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2024
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04130737
Start Date
October 31 2019
End Date
December 24 2024
Last Update
March 7 2024
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
Southwest CVA
Mesa, Arizona, United States, 85206
2
Vascular Heart & Lung Associates
Mesa, Arizona, United States, 85206
3
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States, 85018
4
Yuma Cardiology Associates
Yuma, Arizona, United States, 85349