Tack Optimized Drug Coated Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries (TOBA III)

Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™

This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System. This study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion lengths of ≥20mm and ≤150mm, and have a resulting dissection(s) type(s) A through F. TOBA III will also evaluate the safety and efficacy of the device when used to treat a sub-group presenting with longer lesions of >150mm and ≤250mm.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • University Hospital AKH Vienna
• Belgium
  • Bonheiden, Belgium
    • Imelda Hosptial
  • Dendermonde, Belgium
    • A.Z. St. Blasius Hospital
• Germany
  • Arnsberg, Germany
    • Karolinen-Hospital Klinik für Angiologie Arnsberg Clinic
  • Bad Krozingen, Germany
    • Universitats-Herzzentrum Freiburg-Bad Krozingen Klinik fur Kardiologie und Angiologie lI
  • Berlin, Germany
    • Franziskus-Hospital Berlin
  • Bruchsal, Germany
    • Medizinische Klinik II Fürst Stirum Klinik Bruchsal
  • Dresden, Germany
    • Universitätsklinikum Carl Gustav Carus
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg Herz-, Gefäß- und Therapiezentrum, Abt. Klinische und Interventionelle Angiologie
  • Hamburg, Germany
    • Center for Cardiology & Vascular Intervention
  • Heide, Germany
    • Westküstenklinikum Heide
  • Immenstadt, Germany
    • Herz und Gefäßzentrum im Klinikverbund Oberallgäu-Kempten
  • Karlsbad, Germany
    • Klinikum Karlsbad Langensteinbach
  • Leipzig, Germany
    • Universitätsklinik Leipzig
  • Mainz, Germany, 55131
    • Universitätsmedizin Mainz II Medizinische Klinik und Poliklinik, Angiologie
• Switzerland
  • Lucerne, Switzerland
    • Cantonal Hospital Lucerne Division of Angiology
  • Lugano, Switzerland
    • Ospedale Regionale di Lugano - Civico e Italiana Civico

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:

• 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
  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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tack Implant; Implantation of a Tack implant using the Intact Vascular Tack Endovascular System for the repair of post DCB-angioplasty dissections.	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
Safety - Freedom from the occurrence of any new-onset major adverse event(s)	Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.	30 days
Efficacy - Primary Patency	Primary patency defined as freedom from CEC adjudicated clinically driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as PSVR >2.5:1).	12 months

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Marianne Brodmann, MD, Medical University Hospital Graz

Publications and helpful links

General Publications

• Brodmann M, Wissgott C, Brechtel K, Nikol S, Zeller T, Lichtenberg M, Blessing E, Gray W; TOBA III Investigators. Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results. J Vasc Surg. 2020 Nov;72(5):1636-1647.e1. doi: 10.1016/j.jvs.2020.01.078. Epub 2020 May 12.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: PAD; Claudication; Lesion; Peripheral Artery Disease; Angioplasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CA 0135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No