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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802306
Recruitment Status : Active, not recruiting
First Posted : June 16, 2016
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Intact Vascular

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Tack Endovascular System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
Study Start Date : June 2016
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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




Primary Outcome Measures :
  1. Safety - Freedom from the occurrence of any new-onset major adverse event(s) [ Time Frame: 30 days ]
    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.

  2. Efficacy - Primary Patency [ Time Frame: 12 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802306


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

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Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT02802306     History of Changes
Other Study ID Numbers: CA 0135
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Intact Vascular:
Angioplasty
Peripheral Artery Disease
PAD
Lesion
Claudication
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases