Clinical trial NCT02802306: Tack Optimized Drug Coated Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
Official title: Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Angioplasty
Peripheral Artery Disease
PAD
Lesion
Claudication
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 201
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety - Freedom from the occurrence of any new-onset major adverse event(s)
timeFrame: 30 days
measure: Efficacy - Primary Patency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: University Hospital AKH Vienna
city: Bonheiden
country: Belgium
facility: Imelda Hosptial
city: Dendermonde
country: Belgium
facility: A.Z. St. Blasius Hospital
city: Arnsberg
country: Germany
facility: Karolinen-Hospital Klinik für Angiologie Arnsberg Clinic
city: Bad Krozingen
country: Germany
facility: Universitats-Herzzentrum Freiburg-Bad Krozingen Klinik fur Kardiologie und Angiologie lI
city: Berlin
country: Germany
facility: Franziskus-Hospital Berlin
city: Bruchsal
country: Germany
facility: Medizinische Klinik II Fürst Stirum Klinik Bruchsal
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg Herz-, Gefäß- und Therapiezentrum, Abt. Klinische und Interventionelle Angiologie
city: Hamburg
country: Germany
facility: Center for Cardiology & Vascular Intervention
city: Heide
country: Germany
facility: Westküstenklinikum Heide
city: Immenstadt
country: Germany
facility: Herz und Gefäßzentrum im Klinikverbund Oberallgäu-Kempten
city: Karlsbad
country: Germany
facility: Klinikum Karlsbad Langensteinbach
city: Leipzig
country: Germany
facility: Universitätsklinik Leipzig
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz II Medizinische Klinik und Poliklinik, Angiologie
city: Lucerne
country: Switzerland
facility: Cantonal Hospital Lucerne Division of Angiology
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano - Civico e Italiana Civico
Study officials:
affiliation: Medical University Hospital Graz
name: Marianne Brodmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.