The DETOUR2 Clinical Study

Peripheral Arterial Disease Clinical Trial

Official title:

The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03119233
• Other study ID #: STP 203
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: November 23, 2023

Study information

• Verified date: March 2023
• Source: PQ Bypass, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Description:

The DETOUR2 study is a prospective, single-arm, multi-center, international, non-randomized, safety and effectiveness clinical investigation of the PQ Bypass system.

The PQ Bypass System is intended to improve blood flow in patients with symptomatic peripheral arterial disease due to symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), with reference vessel diameters ranging from 5.0 - 6.7 mm, by investigator visual assessment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: November 23, 2023
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in the study:

General Inclusion Criteria

1. Age > 18 and = 90 years of age.

2. Willing and able to provide informed consent.

3. Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months.

Clinical Inclusion Criteria

4. Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5.

5. Venous Clinical Severity Score < 3.

6. Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.

Angiographic Inclusion Criteria

7. Symptomatic femoropopliteal chronic total occlusions = 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions = 24 cm (total lesion length) that can include a chronic total occlusion or a =70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), by investigator visual assessment.

8. Reference vessel diameter = 4.5 and = 6.7 mm, by investigator visual assessment.

9. Subject has a patent popliteal artery (<50% stenosis) distal to the landing zone

10. Able to successfully access the SFA origin for entry of the crossing device.

11. At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle or foot.

12. A significant stenosis (= 50%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.

General Exclusion Criteria

1. Participating in another investigational clinical study.

2. Anticipated life expectancy less than 1 year or medical comorbid condition(s) that could limit the subject's ability to comply with the requirements of the trial.

3. Subject 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.

Clinical Exclusion Criteria

4. History of deep vein thrombosis on either limb.

5. Thrombophlebitis, within the previous 30 days.

6. 6. Planned major amputation of the target limb, including minor amputation (above the ankle).

7. Prior distal amputation (above the transmetatarsal) of the target limb.

8. Known or suspected active infection at the time of the procedure (e.g., WIfI foot infection grade 3: Severe infection. Local infection with systemic inflammatory response syndrome [SIRS])

9. Rutherford clinical category 0, 1, 2 or 6.

10. Has acute or chronic renal disease with GFR = 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis.

11. Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed.

12. Morbid obesity that does not allow for safe vascular access or imaging.

13. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR > 1.8.

14. Requires coronary or peripheral procedure within 30 days prior to or planned within 30 days post treatment of the target lesion.

15. Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months.

16. Subject is pregnant or breast-feeding. Angiographic Exclusion Criteria

17. Stent within 3 cm of SFA ostium.

18. Previous bypass surgery on the target limb.

19. Subject 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)

20. Presence of aneurysm or acute thrombus in the target limb.

21. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• PQ Bypass System
Intended use from CLN114 Rev F (CLN114 is the DETOUR2 protocol) The PQ Bypass System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions = 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths =24 cm that can include chronic total occlusions or a =70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C).

Locations

Country	Name	City	State
Germany	Klinikum Hochsauerland GmbH	Arnsberg
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt
Germany	Universität Leipzig	Leipzig
Latvia	Pauls Stradins Clinical University Hospital	Riga
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	McLaren Bay Region Hospital	Bay City	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bay Area Vein and Vascular	Burlingame	California
United States	Christie Clinic	Champaign	Illinois
United States	The Christ Hospital - The Carl & Edyth Lindner Center for Research & Education	Cincinnati	Ohio
United States	Cleveland Clinical Foundation	Cleveland	Ohio
United States	North Dallas Research Associates	Dallas	Texas
United States	The Vascular Experts	Darien	Connecticut
United States	Denver VA Medical Center	Denver	Colorado
United States	AMITA Health Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Advanced Cardiac and Vascular Amputation Prevention Centers	Grandville	Michigan
United States	Greenville Health System	Greenville	South Carolina
United States	MedStar Health Research Institute	Hyattsville	Maryland
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	St. Bernard's Medical Center	Jonesboro	Arkansas
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Texas Tech	Lubbock	Texas
United States	Baptist Hospital Miami	Miami	Florida
United States	Aurora Research Institute	Milwaukee	Wisconsin
United States	Community Hospital of the Monterrey Peninsula	Monterey	California
United States	Advanced Cardiovascular Specialists	Mountain View	California
United States	New York-Presbyterian / Columbia University Medical Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Cardiac & Vascular Research Center of Nothern Michigan	Petoskey	Michigan
United States	Miriam Hospital	Providence	Rhode Island
United States	North Caroline Hearth and Vascular- University of North Carolina Rex	Raleigh	North Carolina
United States	HonorHealth	Scottsdale	Arizona
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Cardiology Associates of North Mississippi	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
PQ Bypass, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	The absence of clinically-driven target lesion revascularization and/or absence of recurrent target lesion diameter stenosis >50% by imaging (e.g., duplex ultrasound (peak systolic velocity ratio of >2.5) or invasive angiography) with the stent or immediately 1 cm above or below the treated segment.). When both modalities are available, angiography takes precedence.	12 months
Primary	Primary Safety Endpoint	Freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery.	30 days