Clinical trial NCT02942966: Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
Official title: Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Angioplasty
Below the Knee
PAD
Critical Limb Ischemia
Lesion
Claudication
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2016-10-24
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days
timeFrame: 6 months
measure: Safety - Number of Participants With MALE Plus POD at 30 Days
timeFrame: 30 days
Secondary outcomes:
measure: Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months
timeFrame: 6 months
measure: Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Elk Grove Village
country: United States
facility: Amita Health Cardiovascular Associates
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Heart & Vascular
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, PA
state: New Mexico
city: Matthews
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Research Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals, Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: Einstein Healthcare Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Palmetto Health USC Medical Group
state: South Carolina
city: Jackson
country: United States
facility: Kore Cardiovascular Research
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Institute
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
city: Graz
country: Austria
facility: Division of Angiology, Medical University Graz
city: Brno
country: Czechia
facility: St. Anne's University Hospital Brno
city: Arnsberg
country: Germany
facility: Karolinen-Hospital
city: Berlin
country: Germany
facility: Franziskus-Hospital Berlin-Radiology
city: Heide
country: Germany
facility: Westküstenklinikum Heide
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mülheim an der Ruhr
country: Germany
facility: Evangelisches Krankenhaus Mülheim an der Ruhr
city: Nordheide
country: Germany
facility: Krankenhaus Buchholz
city: Sonneberg
country: Germany
facility: MEDINOS Kliniken des Landkreises Sonneberg GmbH
city: Budapest
country: Hungary
facility: Heart & Vascular Center - Semmelweis University
city: Kecskemét
country: Hungary
facility: Bács-Kiskun County Hospital
city: Auckland
country: New Zealand
facility: Auckland Hospital
Study officials:
affiliation: Washington University School of Medicine in St. Louis
name: Patrick J. Geraghty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rex Hospital
name: George Adams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.
citation: Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
citation: Adams GL, Lichtenberg M, Wissgott C, Schmidt A, Tarra T, Matricardi S, Geraghty PJ. Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries. J Endovasc Ther. 2023 Jun;30(3):393-400. doi: 10.1177/15266028221083462. Epub 2022 Mar 30.
citation: Geraghty PJ, Adams GL, Schmidt A, Lichtenberg M, Wissgott C, Armstrong EJ, Hertting K; TOBA II BTK investigators. Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK). J Endovasc Ther. 2020 Aug;27(4):626-636. doi: 10.1177/1526602820944402.