TORUS 2 IDE Clinical Study

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04130737
• Other study ID #: CLN 227
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: December 24, 2024

Study information

• Verified date: March 2024
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: December 24, 2024
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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, ultrasound, MRA, or CT 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 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).

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. 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).

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 any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.

4. Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.

5. Patient has a target vessel that has been treated with bypass surgery.

6. Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.

7. Patient has known or suspected active systemic infection at the time of enrollment.

8. 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.

9. Patient has a stroke diagnosis within three months prior to enrollment.

10. Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.

11. Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.

12. Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.

13. Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).

14. Patient has received thrombolysis within 72 hours prior to the index procedure.

15. 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.

16. Patient requiring coronary intervention within seven days prior to enrollment.

17. Patient is pregnant or breast-feeding.

18. Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device).

19. 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.

20. 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).

21. Patient has no patent (= 50% stenosis) outflow vessel providing run-off to the ankle.

22. There is a lack of full expansion in the predilatation balloon.

23. Evidence of aneurysm or acute thrombus in target vessel.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VAMC	Aurora	Colorado
United States	McLaren Bay Region	Bay City	Michigan
United States	Bay Area Vein & Vascular Institute	Burlingame	California
United States	Novant Health	Charlotte	North Carolina
United States	The Lindner Center for Research & Education	Cincinnati	Ohio
United States	The Vascular Experts	Darien	Connecticut
United States	AMITA Health	Elk Grove	Illinois
United States	Michigan Vascular Center	Flint	Michigan
United States	Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Bellin Hospital	Green Bay	Wisconsin
United States	Prisma Health	Greenville	South Carolina
United States	MedStar Health Research Insitute	Hyattsville	Maryland
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Arkansas Heart	Little Rock	Arkansas
United States	Texas Tech	Lubbock	Texas
United States	North Dallas Research Associates	McKinney	Texas
United States	Southwest CVA	Mesa	Arizona
United States	Vascular Heart & Lung Associates	Mesa	Arizona
United States	Palm Vascular Centers	Miami Beach	Florida
United States	Columbia University Medical Center	New York	New York
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Naadi	Oklahoma City	Oklahoma
United States	Coastal Vascular & Interventional	Pensacola	Florida
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	The Miriam Hospital	Providence	Rhode Island
United States	NC Heart & Vascular Research	Raleigh	North Carolina
United States	Eastlake Cardiovascular	Roseville	Michigan
United States	UCSF	San Francisco	California
United States	North Central Heart	Sioux Falls	South Dakota
United States	Northern Mississippi Medical Center	Tupelo	Mississippi
United States	Florida Cardiology	Winter Park	Florida
United States	Yuma Cardiology Associates	Yuma	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Endologix	PQ Bypass, Inc., Syntactx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from a Major Adverse Event (MAE)	An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)	30 days
Primary	Primary Patency	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.	12 months
Secondary	Technical Success	Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of =30%	At the time of the index procedure
Secondary	Procedural Success	Procedural Success is defined as technical success with out any MAEs.	Within 24 hours of the procedure
Secondary	Major Adverse Event (MAE) Rate	Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR).	12 months
Secondary	Patency Rate	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.	Through 36 months
Secondary	Assisted Primary Patency Rate	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.	Through 36 months
Secondary	Secondary Patency Rate	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.)	Through 36 months
Secondary	Alternative Patency Rate	Patency of target vessel based on systolic velocity ratio = 2.0 and absence of CD-TLR.	Through 36 months
Secondary	Walking Improvement Questionnaire (WIQ) Assessment	Assessment of walking improvement	From procedure to 1, 6 and 12 months
Secondary	Quality of Life Assessment by the EQ5D	Assessment of improved quality of life	From procedure to 1, 6 and 12 months
Secondary	Clinically Driven Target Lesion Revascularization		Through 36 months
Secondary	Target Vessel Revascularization		Through 36 months
Secondary	Major Amputation on Target Limb		Through 36 months
Secondary	Stent Fracture Rate	Stent fracture rate using VIVA definitions	12 months
Secondary	Change in Ankle-Brachial Index		From procedure through 36 months
Secondary	Change in Toe Pressures		From procedure through 36 months
Secondary	Change in Rutherford Clinical Classification		From procedure through 36 months
Secondary	Adverse Event Rate		Through 36 months