Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:February 8, 2017
End Date:October 2022
Contact:Joseph C Griffin, III
Email:jgriffin@intactvascular.com
Phone:484-253-1043

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Tack Optimized Balloon Angioplasty Study for the Below The Knee 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 the Mid/Distal Popliteal, Tibial,
and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post
percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.


Inclusion Criteria:

- Males or non-pregnant females ≥ 18 years of age at the time of consent

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

- Subject 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 informed consent form (ICF), an impartial witness may sign on
behalf of the subject

- Willing to comply with all required follow-up visits

- Rutherford Classification 4 or 5.

- WIfI Wound grade of 0, 1 or modified 2.

- WIfI Foot Infection grade of 0 or 1.

- Estimated life expectancy ≥1 year

Exclusion Criteria:

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

- Previous bypass graft in the target limb

- Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the
index procedure

- Prior or planned above-ankle amputation or complete transmetatarsal amputation to the
target limb (this does not apply to ray amputation of ≤2 digits, simple digital
amputations or ulcer debridements)

- WIfI Foot Infection grade 2 or 3

- Any systemic infection or immunocompromised state. Patients with an ascending
infection/deep foot infection or abscess/white blood count (WBC)≥12,000/or febrile
state

- Endovascular or surgical procedure (not including diagnostic procedures, planned
simple digital amputation or wound debridement) to the target limb less than 30 days
prior to or planned for less than 30 days after the index procedure

- Existing stent implant in the target vessel

- Any other endovascular or surgical procedure (not including diagnostic procedures,
planned simple digital amputation or wound debridement) less than 14 days prior to the
index procedure or planned procedure less than 30 days after the index procedure

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

- WIfI Wound grade of 2 or 3.

- Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is
contraindicated

- Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the
Index Procedure

- History of stroke or transient ischemic attack (TIA) less than 90 days prior to the
Index Procedure

- Currently on dialysis

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

- Participating in another ongoing investigational clinical trial in which the subject
has not completed the primary endpoint(s)

- 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

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

- Subject already enrolled into this study

- Restenotic target lesion previously treated by means other than plain balloon
angioplasty and/or less than 1 year prior to index procedure.
We found this trial at
38
sites
Browns Mills, New Jersey 08015
Phone: 609-893-6611
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 713-798-1037
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Albuquerque, New Mexico 87102
Phone: 505-841-1000
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Atlanta, Georgia 30309
Phone: 404-605-2800
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Bellevue, Washington 98004
Phone: 425-453-1772
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Cincinnati, Ohio 45219
Phone: 513-515-1777
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Cleveland, Ohio 44012
Phone: 216-844-3130
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Columbia, South Carolina 29203
Phone: 803-545-5802
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Columbus, Ohio 43214
Phone: 614-262-6772
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Davenport, Iowa 52803
Phone: 563-320-0263
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Denver, Colorado 80220
Phone: 303-399-8020
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22101 Moross Road
Detroit, Michigan 48236
Phone: 586-498-0440
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Detroit, MI
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800 Biesterfield Rd # G101
Elk Grove Village, Illinois 60007
Phone: 847-981-3680
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Flint, Michigan 98507
Phone: 810-600-2009
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Fremont, California
Phone: 510-796-0222
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Galveston, Texas
Phone: 409-772-6366
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2 Auenbruggerplatz
Graz, 8036
Phone: 0043 316 385 80286
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Houma, Louisiana 70360
Phone: 985-876-0300
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Huntsville, Texas 77340
Phone: 601-813-1345
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Jackson, Tennessee 38305
Phone: 731-512-0104
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Jacksonville, Florida 32216
Phone: 904-493-3333
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1401 Matthews Township Parkway
Matthews, North Carolina 28204
Phone: 704-264-1400
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McKinney, Texas 75069
Phone: 972-562-2345
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Nashville, Tennessee 37203
Phone: 615-329-7887
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New Braunfels, Texas 78130
Phone: 830-620-1272
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Phone: 301-367-0397
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Norfolk, Virginia 23507
Phone: 757-359-1600
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Norfolk, VA
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Phone: 708-636-7575
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Philadelphia, Pennsylvania 19141
Phone: 215-456-1959
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Plano, Texas 75093
Phone: 469-800-6100
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Phone: 401-793-4105
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Raleigh, North Carolina 27607
Phone: 919-350-8317
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Raleigh, North Carolina
Phone: 919-781-7772
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Saint Louis, Missouri 63136
Phone: 314-741-0911
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Teaneck, New Jersey 07666
Phone: 201-541-6312
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Tyler, Texas 75701
Phone: 903-595-2283
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Washington, District of Columbia
Phone: 202-877-5975
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Yuma, Arizona 85364
Phone: 928-341-9522
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