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

This study is currently recruiting participants.
Verified March 2017 by Intact Vascular
Sponsor:
ClinicalTrials.gov Identifier:
NCT02802306
First Posted: June 16, 2016
Last Update Posted: May 10, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Intact Vascular
  Purpose
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 Intervention
Peripheral Arterial Disease Device: Tack Endovascular System

Study Type: Interventional
Study Design: 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™

Resource links provided by NLM:


Further study details as provided by Intact Vascular:

Primary Outcome Measures:
  • 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.

  • Efficacy [ 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).


Estimated Enrollment: 200
Study Start Date: June 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Joseph C Griffin, III 484-253-1043 jgriffin@intactvascular.com

Locations
Austria
University Hospital AKH Vienna Recruiting
Wien, Austria
Contact: Florian Wolf, MD    43 1 40400 58020      
Contact: Johanna Moyses    43 1 40400 58900      
Belgium
Imelda Hosptial Recruiting
Bonheiden, Belgium
Contact: Patrick Peeters, Dr.    32 15 50 6182      
Contact: Wendy Janssens    32 15 50 6182      
A.Z. St. Blasius Hospital Recruiting
Dendermonde, Belgium
Contact: Marc Bosiers, MD    32 052 25 27 35      
Contact: Jereon Wauters    32 52 25 28 22      
Germany
Karolinen-Hospital Klinik für Angiologie Arnsberg Clinic Recruiting
Arnsberg, Germany
Contact: Michael Lichtenberg, MD    49 2932 952 1271      
Contact: Martin Kuhmann, MD    49 0932 952 1271      
Universitats-Herzzentrum Freiburg-Bad Krozingen Klinik fur Kardiologie und Angiologie lI Recruiting
Bad Krozingen, Germany
Contact: Thomas Zeller, Prof. Dr.    49 7633 402 4973      
Contact: Verena Zahringer    49 7633 402 4978      
Franziskus-Hospital Berlin Recruiting
Berlin, Germany
Contact: Klaus Brechtel, MD    (49) 3032 29 13 190      
Contact: Richard Wegner    (49) 3026 38 34 12      
Medizinische Klinik II Fürst Stirum Klinik Bruchsal Recruiting
Bruchsal, Germany
Contact: Martin Andrassy, MD    49 7251 708 58302      
Contact: Manuela Scherer-Stolz    49 7251 708 58506      
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Germany
Contact: Norbert Weiss, MD    (49) 351 458 3659      
Contact: Elke Festerling    (49) 351 458 3156      
Asklepios Klinik St. Georg Herz-, Gefäß- und Therapiezentrum, Abt. Klinische und Interventionelle Angiologie Recruiting
Hamburg, Germany, 20099
Contact: Sigrid Nikol, Prof. Dr.    (49) 40 1818 85 2401      
Contact: Katrin Borchers    (49) 40 1818 85 2527      
Center for Cardiology & Vascular Intervention Recruiting
Hamburg, Germany
Contact: Sebastian Sixt, Dr.    49 40 889 009 889      
Contact: Kerstin Flint    49 40 889 009 889      
Westküstenklinikum Heide Recruiting
Heide, Germany
Contact: Christian Wissgott, MD    (49) 481-785-2431      
Herz und Gefäßzentrum im Klinikverbund Oberallgäu-Kempten Recruiting
Immenstadt, Germany
Contact: Wulf Ito, MD    49 8323 910 8701      
Contact: Jacqueline Fielder    49 8323 910 8909      
Klinikum Karlsbad Langensteinbach Recruiting
Karlsbad, Germany
Contact: Erwin Blessing, Prof. Dr.    49 7202 61 3340      
Contact: Bernd Kroeg    49 7202 61 7216      
Universitätsklinik Leipzig Recruiting
Leipzig, Germany
Contact: Dierk Scheinert, MD    (49) 341 9718770      
Contact: Janin Lenzer    (49) 341 9718774      
Universitätsmedizin Mainz II Medizinische Klinik und Poliklinik, Angiologie Recruiting
Mainz, Germany, 55131
Contact: Christine Espinola-Klein, Prof. Dr.    (49) 6131 17 39 60      
Contact: Gerhard Weisser    (49) 6131 17 39 60      
Switzerland
Cantonal Hospital Lucerne Division of Angiology Recruiting
Lucerne, Switzerland
Contact: Martin Banyai, Dr.    41 41 205 22 39      
Contact: Virginia Justi    41 41 205 52 30      
Ospedale Regionale di Lugano - Civico e Italiana Civico Recruiting
Lugano, Switzerland
Contact: Jos Van den Berg, PD Dr.    41 (0) 91 811 60 72      
Sponsors and Collaborators
Intact Vascular
Investigators
Principal Investigator: Marianne Brodmann, MD Medical University Hospital Graz
  More Information

Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT02802306     History of Changes
Other Study ID Numbers: CA 0135
First Submitted: June 13, 2016
First Posted: June 16, 2016
Last Update Posted: May 10, 2017
Last Verified: March 2017
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:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases