TORUS 2 IDE Clinical Study

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    188
  • sponsor
    PQ Bypass, Inc.
Updated on 30 August 2020
arteriopathy
angiography
stenosis
endovascular intervention
vascular disease
stenotic

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.

Details
Treatment TORUS Stent Graft System
Clinical Study IdentifierNCT04130737
SponsorPQ Bypass, Inc.
Last Modified on30 August 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 90 yrs?
Gender: Male or Female
Do you have any of these conditions: Peripheral vascular disease or Circulation Disorders or Peripheral Arterial Disease (PAD) or peripheral arterial disease?
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 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 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 mol/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
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