Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:September 2015
End Date:June 2020

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Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate
the safety and efficacy of the Tack Endovascular System in subjects with post-balloon
angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and
proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.


Inclusion Criteria:

- Subject must meet all of the following inclusion criteria to be eligible for
enrollment:

1. Male or non-pregnant Female ≥ 18 years of age at the time of consent

2. Female subjects of childbearing potential must have a negative pregnancy test
prior to treatment and must use some form of contraception through the duration
of the study (abstinence is acceptable)

3. Target limb requires no additional treatment aside from the target lesion and the
iliac artery(ies) during the index procedure

4. Subject or has been informed of and understands the nature of the study and
provides signed informed consent to participate in the study. If the subject
possesses the ability to understand and provide informed consent but due to
physical inability, the subject cannot sign the ICF, an impartial witness may
sign on behalf of the subject

5. Willing to comply with all required follow-up visits

6. Rutherford Classification 2, 3 or 4

7. Estimated life expectancy >1 year

8. Eligible for standard surgical repair, if necessary

9. Subject is ambulatory (assistive devices such as a cane or walker is acceptable)

Exclusion Criteria:

- Subject must NOT meet any of the following exclusion criteria to be eligible for
enrollment:

1. Rutherford Classification 0, 1, 5 or 6

2. Is pregnant or refuses to use contraception through the duration of the study

3. Previous infrainguinal bypass graft in the target limb

4. Planned amputation on the target limb

5. Systemic infection or Infection within the target limb and/or immunocompromised

6. Endovascular or surgical procedure (not including diagnostic procedures) on the
target limb within 30 days prior to or within 30 days after the index procedure

7. Endovascular or surgical procedure (not including diagnostic procedures) on the
non-target limb within 14 days prior to the index procedure or planned procedure
within 30 days after the index procedure

8. Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention
(PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI
within 30 days after the index procedure

9. Any other previous or planned surgical or endovascular procedure (not including
diagnostic procedures) within 14 days prior to or 30 days post index procedure

10. Planned atherectomy, cryoplasty, stenting or any other treatment (with the
exception of a crossing device) of the target lesion other than PTA during the
index procedure

11. Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood
disorder, or a platelet count less than 80,000/microliter or greater than
500,000/microliter

12. Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy

13. Myocardial infarction within 30 days prior to enrollment

14. History of stroke within 90 days prior to enrollment

15. Serum creatinine of >2.5 mg/dL

16. Requires treatment of tibial or outflow vessels at the index procedure, which
include the P2 and P3 segments of the popliteal artery and the tibioperoneal
vessels

17. Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)

18. Participating in another ongoing investigational clinical trial that has not
completed its primary endpoint

19. Has other comorbidities that, in the opinion of the investigator, would preclude
them from receiving this treatment and/or participating in study-required
follow-up assessments

20. Known hypersensitivity or allergy to contrast agents that cannot be medically
managed

21. Thrombolysis of the target vessel within 72 hours prior to the index procedure,
where complete resolution of the thrombus was not achieved
We found this trial at
37
sites
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Phone: 203-785-4129
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-1372
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-500-5911
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: 319-356-4791
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Albuquerque, New Mexico 87102
Phone: 505-841-1000
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Beverly Hills, California 90211
Phone: 310-248-8245
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875 Poplar Church Road
Camp Hill, Pennsylvania 17011
Phone: 717-724-6450
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-876-4737
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Columbus, Ohio 43214
Phone: 614-566-1250
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Davenport, Iowa 52803
Phone: 563-320-0263
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Denver, Colorado 80220
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Elk Grove Village, Illinois 60007
Phone: 847-427-7230
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Fremont, California
Phone: 510-796-0222
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Gainesville, Florida 32605
Phone: 352-333-0939
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Graz,
Phone: 43 316 385 80286
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-9600
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kingsport, Tennessee 37660
Phone: 423-230-5640
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LaGrange, Illinois 60439
Phone: 708-245-8161
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Langhorne, Pennsylvania 19047
Phone: 215-710-6060
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Little Rock, Arkansas 72205
Phone: 501-257-6917
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McKinney, Texas 75069
Phone: 972-562-2345
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New Braunfels, Texas 78130
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Norfolk, Virginia 23507
Phone: 757-395-1600
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Orange, California 92868
Phone: 714-771-8111
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Philadelphia, Pennsylvania 19141
Phone: 215-456-7054
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Phone: 401-793-7191
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Raleigh, North Carolina 27610
Phone: 919-350-8317
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2800 Blue Ridge Road
Raleigh, North Carolina 27610
Phone: 919-350-8317
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Sioux Falls, South Dakota 57018
Phone: 605-977-5000
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Springfield, Illinois 62701
Phone: 217-492-9100
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Teaneck, New Jersey 07666
Phone: 201-541-6312
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Washington, District of Columbia
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Wormleysburg, Pennsylvania 17043
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Wynnewood, Pennsylvania 19096
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5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Phone: 616-252-7446
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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Yuma, Arizona 85364
Phone: 928-341-9522
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