Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries (TOBA II BTK)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Tack Endovascular System

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Division of Angiology, Medical University Graz
• Czechia
  • Brno, Czechia
    • St. Anne's University Hospital Brno
• Germany
  • Arnsberg, Germany, 59759
    • Karolinen-Hospital
  • Berlin, Germany, 10787
    • Franziskus-Hospital Berlin-Radiology
  • Heide, Germany, 25746
    • Westküstenklinikum Heide
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig
  • Mülheim an der Ruhr, Germany
    • Evangelisches Krankenhaus Mulheim an der Ruhr
  • Nordheide, Germany, 21244
    • Krankenhaus Buchholz
  • Sonneberg, Germany, 96515
    • MEDINOS Kliniken des Landkreises Sonneberg GmbH
• Hungary
  • Budapest, Hungary, 1122
    • Heart & Vascular Center - Semmelweis University
  • Kecskemét, Hungary
    • Bács-Kiskun County Hospital
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland Hospital
• United States
  • Arizona
    • Yuma, Arizona, United States, 85364
      • Yuma Regional Medical Center
  • California
    • Fremont, California, United States, 94538
      • Mission Cardiovascular Research Institute
  • Colorado
    • Denver, Colorado, United States, 80220
      • Denver VA Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32256
      • First Coast Cardiovascular Institute
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Amita Health Cardiovascular Associates
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Michigan
    • Detroit, Michigan, United States, 48215
      • Ascension St. John Hospital
    • Flint, Michigan, United States, 48507
      • Michigan Vascular Center
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart & Vascular
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute, PA
  • North Carolina
    • Matthews, North Carolina, United States, 28204
      • Novant Health Heart and Vascular Institute
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital
    • Raleigh, North Carolina, United States, 27609
      • WakeMed Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Research Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals, Cleveland Medical Center
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Healthcare Network
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health USC Medical Group
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Kore Cardiovascular Research
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch at Galveston
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates
    • New Braunfels, Texas, United States, 78130
      • Mission Research Institute
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • Tyler, Texas, United States, 75701
      • Cardiovascular Associates of East Texas
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Vascular Specialists
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tack Implant; Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee.	Device: Tack Endovascular System; Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.; Other Names: Post-PTA Dissection Repair Implant; Tack Implant; Tack Dissection Repair Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days	Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.	6 months
Safety - Number of Participants With MALE Plus POD at 30 Days	Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months	Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.	6 months
Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months	Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.	6 months

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Patrick J. Geraghty, MD, Washington University School of Medicine in St. Louis

Publications and helpful links

General Publications

• 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.
• 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.
• 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. 2022 Mar 30:15266028221083462. doi: 10.1177/15266028221083462. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2017
• Primary Completion (ACTUAL): July 11, 2019
• Study Completion (ACTUAL): January 10, 2022

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (ESTIMATE): October 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: PAD; Claudication; Lesion; Angioplasty; Critical Limb Ischemia; Below the Knee
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CA 0137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes