The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2

  • STATUS
    Recruiting
Updated on 23 November 2020
Investigator
Volunteers, clinicalresearch@amitahealth.org
Primary Contact
AMITA Health (5.7 mi away) Contact

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 native SFA or the superficial femoral and/or proximal popliteal arteries.

Description

Details
Condition Peripheral Arterial Disease (PAD)
Clinical Study IdentifierTX246588
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

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 or ultrasound 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 or multiple target lesions must be covered by a single stent. In the case of tandem target lesions, the gap between lesions must be ≤ 2.5 cm
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
Single or multiple target lesions measure ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate
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 Criteria

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 an iliac stent in target limb that has required re-intervention within 12 months prior to index
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
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