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The DETOUR II Clinical Study

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ClinicalTrials.gov Identifier: NCT03119233
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
PQ Bypass, Inc.

Brief Summary:
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) bypass.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: PQ Bypass System Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PQ Bypass System for Femoropopliteal Bypass II
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single-Arm
The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.
Device: 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 femoro-popliteal arteries, including in-stent re-stenosis, with reference vessel diameters ranging from 5.0 - 6.7 mm




Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ Time Frame: 12 months ]
    The rate of primary patency at 12 months defined as: no evidence of clinically significant stenosis (>/= 50%) based on duplex ultrasound (peak systolic velocity ratio of >2.5) within the stent graft or immediately above or below the treated arterial segment, and no clinically-driven re-intervention within the stented segment.

  2. Primary Safety Endpoint [ Time Frame: 30 days ]
    Freedom from a major adverse event (MAE) at 30 days post-procedure. MAE includes: Death; Target lesion revascularization (TLR) defined as any repeat percutaneous intervention of the target lesions (including 5 mm proximal and distal to the index device) or surgical bypass of the target vessel performed for the restenosis or other complication involving the target lesion; amputation of the treated limb; symptomatic deep vein thrombosis (DVT); pulmonary embolism (PE); and, procedure related bleeding requiring any transfusion of packed red blood cells or surgery.



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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:

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 foot.
  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 study.
  23. A condition that in the view of the investigator precludes participation in this study.

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): NCT03119233


Contacts
Contact: Bradley Brown, MS, MBA +1 (804) 638-8598 bbrown@pqbypass.com
Contact: Jeremy Moyer, MS +1 (610) 509-6727 jmoyer@pqbypasss.com

Locations
United States, Arkansas
St. Bernard's Medical Center Recruiting
Jonesboro, Arkansas, United States, 72401
Principal Investigator: Max Arroyo, MD         
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Principal Investigator: Vasili Lendel, MD         
United States, California
Advanced Cardiovascular Specialists Recruiting
Mountain View, California, United States, 94040
Principal Investigator: Ajanta De, MD         
United States, Colorado
Denver VA Medical Center Recruiting
Denver, Colorado, United States, 80220
Principal Investigator: Ehrin Armstrong, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Carlos Mena, MD         
United States, Illinois
Prairie Education and Research Cooperative Recruiting
Springfield, Illinois, United States, 62701
Principal Investigator: Jeffrey Goldstein, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Matt Eagleton, MD         
United States, Michigan
Cardiac & Vascular Research Center of Nothern Michigan Recruiting
Petoskey, Michigan, United States, 49770
Principal Investigator: Jason Ricci, MD         
United States, New Jersey
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Principal Investigator: John Rundback, MD         
United States, New Mexico
New Mexico Heart Institute Not yet recruiting
Albuquerque, New Mexico, United States, 87102
Principal Investigator: Steve Henao, MD         
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Principal Investigator: Richard Schutzer, MD         
United States, Ohio
Cleveland Clinical Foundation Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Sean Lyden, MD         
United States, Rhode Island
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Principal Investigator: Peter Soukas, MD         
United States, Tennessee
Stern Cardiovascular Foundation Recruiting
Germantown, Tennessee, United States, 38138
Principal Investigator: Basil Paulus, MD         
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Principal Investigator: Chris Metzger, MD         
Latvia
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia, 1002
Principal Investigator: Dainis Krievins, MD         
Poland
Gdańsk Medical University Recruiting
Gdańsk, Poland
Principal Investigator: Grzegorz Halena, MD         
Sponsors and Collaborators
PQ Bypass, Inc.
Investigators
Principal Investigator: Jihad Mustapha, MD Metro Health Hospital
Principal Investigator: Sean Lyden, MD The Cleveland Clinic

Responsible Party: PQ Bypass, Inc.
ClinicalTrials.gov Identifier: NCT03119233     History of Changes
Other Study ID Numbers: STP 203
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases