The DETOUR II Clinical Study

Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - 90
Start Date:December 13, 2017
End Date:June 2022
Contact:Bradley Brown, MS, MBA
Phone:+1 (804) 638-8598

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PQ Bypass System for Femoropopliteal Bypass II

The study is 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)

The DETOUR II 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 >15 cm long occlusions and diffuse stenoses of
femoropopliteal arteries, including in-stent re-stenosis, with reference vessel diameters
ranging from 5.0 - 6.7 mm.

Inclusion Criteria:

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

1. Age 18 or older.

2. Willing and able to provide informed consent.

3. Severe claudication or rest pain or ischemic ulceration (Rutherford Becker scale 3-5)
with a resting ABI ≤0.9. Resting TBI is utilized only if unable to reliably assess
ABI. Resting TBI must be ≤0.5. Assessments are required for the target limb and
contralateral limb.

4. Venous Clinical Severity Score <3.

5. Femoro-popliteal stenotic lesions >15 cm (TASC C and D) in length considered to be:

- Chronic total occlusion (100% stenosis)

- Diffuse stenosis (>50% stenosis)

- In-stent restenosis (>50% stenosis)

6. Reference vessel diameter (RVD) ≥5.0 mm and ≤6.7 mm, as measured via pre-screening
CTA/MRA using 3D multi-plane reconstruction.

7. Patent iliac and femoral arteries and tibial veins and access vessels, of sufficient
size and morphology (including tortuosity), to allow arterial access with 8 Fr.
introducer sheath.

8. Visible SFA stump at the SFA origin.

9. Significant aortoiliac or common femoral "inflow" lesions (i.e. angiographically
defined >50% stenosis of the iliac or common femoral artery) must be successfully
treated prior to treatment of the target lesion. This can be done just prior to
treatment of the target lesion. Successful treatment is defined as <30% stenosis after
either PTA or stenting of the inflow lesion. After successful treatment of the inflow
lesion, the subject will be included in the study following sheath placement distal to
the treated lesion.

10. A subject with bilateral obstructive SFA disease is eligible for enrollment into the
study. If a subject with bilateral disease is enrolled, and both limbs meet the study
enrollment criteria, the target limb for study treatment will be selected at the
Investigator's discretion. Lesion characteristic such as lesion length, percent
stenosis, and/or calcification content may be used in study treatment decision. The
non-target limb may be treated using currently available (non-investigational) methods
>30 days post index procedure.

11. Non diseased patent popliteal artery 3 cm proximal to tibial plateau.

12. At least 1 continuous patent tibial artery (<50% stenosed) with flow to the ankle or

13. Patent femoral vein ≥10 mm in diameter or duplicate femoral vein.

14. Subject is eligible for standard surgical repair, if necessary.

15. Subject is ambulatory.

16. Subject has >1 year life expectancy.

17. Subject is able to comply with the necessary follow-up examinations and tests in
accordance with protocol.

Exclusion Criteria:

Subjects will be excluded from participating in the study if they meet any of the following
exclusion criteria:

1. Age greater than 90.

2. Acute vessel thrombosis.

3. Thrombophlebitis, within the previous 30 days.

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

5. History of deep vein thrombosis on either limb.

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

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

8. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.

9. Untreated flow-limiting aortoiliac occlusive disease.

10. Has Chronic Kidney Disease stage 4 or greater (eGFR < 30mL/min).

11. History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is
considered to be at risk for reoccurrence.

12. Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that
cannot be corrected.

13. Morbid obesity (BMI >40).

14. Rutherford Class 0 to 2 and 6.

15. Prior major distal amputation (above the transmetatarsal) in the study limb.

16. Planned amputation of the target limb.

17. Known or suspected active infection at the time of the procedure.

18. Immunosuppressant therapy within the previous 30 days.

19. Previous bypass surgery on the target limb.

20. Decompensated heart failure (Stage III or IV), COPD FEV1 <30% normal, or <50% normal
with chronic respiratory failure present), metastatic malignancy, dementia, or other
major co-morbidities that would prevent the post-interventional movement.

21. Has known hypersensitivities, allergies or contraindications to: nitinol, PTFE;
aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or
anticoagulation or contrast media that cannot be medically managed.

22. Participating in another clinical study for which follow-up may impact the current

23. A condition that in the view of the investigator precludes participation in this
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Germantown, Tennessee 38138
Principal Investigator: Basil Paulus, MD
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Greenville, South Carolina 29615
Principal Investigator: Bruce Gray, DO
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Jonesboro, Arkansas 72401
Principal Investigator: Max Arroyo, MD
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Kingsport, Tennessee 37660
Principal Investigator: Chris Metzger, MD
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Little Rock, Arkansas 72211
Principal Investigator: Vasili Lendel, MD
Phone: 501-748-8421
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Mountain View, California 94040
Principal Investigator: Ajanta De, MD
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20 York St, N20 York St,
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New York, New York 10065
Principal Investigator: Richard Schutzer, MD
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560 West Mitchell Street
Petoskey, Michigan 49770
Principal Investigator: Jason Ricci, MD
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164 Summit Ave
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(401) 793-2500
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Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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13 Pilsoņu iela
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Teaneck, New Jersey 07666
Principal Investigator: John Rundback, MD
Teaneck, NJ
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