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TORUS 2 IDE Clinical Study

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ClinicalTrials.gov Identifier: NCT04130737
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
PQ Bypass, Inc.

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: TORUS Stent Graft System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TORUS Stent Graft System
The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS).
Device: TORUS Stent Graft System
The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.
Other Names:
  • TORUS Stent Graft
  • PQ Bypass™ Stent Graft System




Primary Outcome Measures :
  1. Freedom from a Major Adverse Event (MAE) [ Time Frame: 30 days ]
    An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)

  2. Primary Patency [ Time Frame: 12 months ]
    Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5.


Secondary Outcome Measures :
  1. Technical Success [ Time Frame: At the time of the index procedure ]
    Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30%

  2. Procedural Success [ Time Frame: Within 24 hours of the procedure ]
    Procedural Success is defined as technical success with out any MAEs.

  3. Major Adverse Event (MAE) Rate [ Time Frame: 12 months ]
    Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR).

  4. Patency Rate [ Time Frame: Through 36 months ]
    Absence of CD-TLR and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5.

  5. Assisted Primary Patency Rate [ Time Frame: Through 36 months ]
    Revascularization of non-occlusive (<99%) stenosis within the stent graft or immediately above or below the treated arterial segment (end of the graft and 1cm of artery beyond) with less than 50% residual stenosis.

  6. Secondary Patency Rate [ Time Frame: Through 36 months ]
    Revascularization of occlusion (100%) within the stent graft or immediately above or below the treated arterial segment (end of the graft and 1cm of artery beyond) with less than 50% residual stenosis.)

  7. Alternative Patency Rate [ Time Frame: Through 36 months ]
    Patency of target vessel based on systolic velocity ratio ≤ 2.0 and absence of CD-TLR.

  8. Walking Improvement Questionnaire (WIQ) Assessment [ Time Frame: From procedure to 1, 6 and 12 months ]
    Assessment of walking improvement

  9. Quality of Life Assessment by the EQ5D [ Time Frame: From procedure to 1, 6 and 12 months ]
    Assessment of improved quality of life

  10. Clinically Driven Target Lesion Revascularization [ Time Frame: Through 36 months ]
  11. Target Vessel Revascularization [ Time Frame: Through 36 months ]
  12. Major Amputation on Target Limb [ Time Frame: Through 36 months ]
  13. Stent Fracture Rate [ Time Frame: 12 months ]
    Stent fracture rate using VIVA definitions

  14. Change in Ankle-Brachial Index [ Time Frame: From procedure through 36 months ]
  15. Change in Toe Pressures [ Time Frame: From procedure through 36 months ]
  16. Change in Rutherford Clinical Classification [ Time Frame: From procedure through 36 months ]
  17. Adverse Event Rate [ Time Frame: Through 36 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is male or female, with age > 18 and ≤ 90 years at date of enrollment.
  2. Patient provides written informed consent before any study-specific investigations or procedures.
  3. Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
  4. Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
  5. 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.
  6. Patient has PAD classified as Rutherford classification 2, 3 or 4.
  7. 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.
  8. 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.
  9. 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.
  10. Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur.
  11. Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate.
  12. Single or multiple target lesions measure ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate.
  13. Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment.
  14. Patient has at least one patent infrapopliteal vessel (< 50% stenosis) with run-off to the ankle.

Exclusion Criteria:

  1. 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.
  2. Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
  3. Patient has an iliac stent in target limb that has required re-intervention within 12 months prior to index.
  4. Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
  5. Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
  6. Patient has a target vessel that has been treated with bypass surgery.
  7. Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.
  8. Patient has known or suspected active systemic infection at the time of enrollment.
  9. 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.
  10. Patient has a stroke diagnosis within three months prior to enrollment.
  11. Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
  12. Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
  13. Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.
  14. Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).
  15. Patient has received thrombolysis within 72 hours prior to the index procedure.
  16. 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.
  17. Patient requiring coronary intervention within seven days prior to enrollment.
  18. Patient is pregnant or breast-feeding.
  19. Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device).
  20. 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.
  21. 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).
  22. Patient has no patent (≥ 50% stenosis) outflow vessel providing run-off to the ankle.
  23. There is a lack of full expansion in the predilatation balloon.
  24. Target lesion requires percutaneous interventional treatment, beyond standard balloon angioplasty alone, prior to placement of the study stent graft.
  25. Evidence of aneurysm or acute thrombus in target vessel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130737


Contacts
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Contact: Malea D'Amico 315-794-4422 clinicalaffairs@pqbypass.com

Locations
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United States, Connecticut
The Vascular Experts Recruiting
Darien, Connecticut, United States, 06820
United States, Florida
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
PQ Bypass, Inc.
Syntactx

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Responsible Party: PQ Bypass, Inc.
ClinicalTrials.gov Identifier: NCT04130737     History of Changes
Other Study ID Numbers: CLN 227
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by PQ Bypass, Inc.:
Peripheral Artery Disease
Superficial Femoral Artery
Popliteal Artery
Stent Graft
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases