The DETOUR 2 Clinical Trial

Endologix

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: DETOUR System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03119233

STP 203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

202 participants in 1 patient group

Single-Arm

Experimental group

Description:

This is a prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the DETOUR System, delivery guidewires, and implant stent grafts for percutaneous femoropoliteal bypass compared to Performance Goals (PG)

Treatment:

Device: DETOUR System