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Peripheral Arterial DiseaseTOBA IIINCT02802306

Tack Optimized Drug Coated Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries

A study testing Tack Endovascular System in people with Peripheral Arterial Disease, run by Philips Clinical & Medical Affairs Global at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Tack Endovascular System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
17 sitesin 4 countries
Study dates
Jun 2016to May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must meet all of the following inclusion criteria to be eligible for enrollment:
  • Male or non-pregnant Female ≥ 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 through the duration of the study
  • Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure
  • 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
  • Willing to comply with all required follow-up visits
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  • Rutherford Classification 2, 3 or 4
  • Estimated life expectancy >1 year
  • Eligible for standard surgical repair, if necessary
  • Subject is ambulatory (assistive devices such as a cane or walker is acceptable

Who cannot join

  • Subject must NOT meet any of the following exclusion criteria to be eligible for enrollment:
  • Rutherford Classification 0, 1, 5 or 6
  • Is pregnant or refuses to use contraception through the duration of the study
  • Previous infrainguinal bypass graft in the target limb
  • Planned amputation on the target limb
  • Systemic infection or infection within the target limb and/or immunocompromised
Show all 22Show fewer
  • 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
  • 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
  • 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
  • Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure
  • 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
  • Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter
  • Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy
  • Myocardial infarction within 30 days prior to enrollment
  • History of stroke within 90 days prior to enrollment
  • Serum creatinine of >2.5 mg/dL
  • 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
  • Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
  • Participating in another ongoing investigational clinical trial that has not completed its primary endpoint
  • 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
  • Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

Germany12 sites

  • Karolinen-Hospital Klinik für Angiologie Arnsberg Clinic

    Arnsberg

  • Universitats-Herzzentrum Freiburg-Bad Krozingen Klinik fur Kardiologie und Angiologie lI

    Bad Krozingen

  • Franziskus-Hospital Berlin

    Berlin

  • Medizinische Klinik II Fürst Stirum Klinik Bruchsal

    Bruchsal

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Asklepios Klinik St. Georg Herz-, Gefäß- und Therapiezentrum, Abt. Klinische und Interventionelle Angiologie

    Hamburg, 20099

  • Center for Cardiology & Vascular Intervention

    Hamburg

  • Westküstenklinikum Heide

    Heide

  • Herz und Gefäßzentrum im Klinikverbund Oberallgäu-Kempten

    Immenstadt im Allgäu

  • Klinikum Karlsbad Langensteinbach

    Karlsbad

  • Universitätsklinik Leipzig

    Leipzig

  • Universitätsmedizin Mainz II Medizinische Klinik und Poliklinik, Angiologie

    Mainz, 55131

Other trials in Germany

Belgium2 sites

  • Imelda Hosptial

    Bonheiden

  • A.Z. St. Blasius Hospital

    Dendermonde

Other trials in Belgium

Switzerland2 sites

  • Cantonal Hospital Lucerne Division of Angiology

    Lucerne

  • Ospedale Regionale di Lugano - Civico e Italiana Civico

    Lugano

Other trials in Switzerland

Austria1 site

  • University Hospital AKH Vienna

    Vienna

Other trials in Austria

About this study

Official title: 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.

Being tested
Tack Endovascular System
Keywords
Angioplasty, Peripheral Artery Disease, PAD, Lesion, Claudication
Medical subject headings
Peripheral Arterial Disease, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tack Endovascular SystemDevice

    Also called Post-PTA Dissection Repair Implant, Tack Implant, Tack Dissection Repair Device

    Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System

Study groups in NCT02802306
Study groupRoleWhat they receive
Tack ImplantExperimentalImplantation of a Tack implant using the Intact Vascular Tack Endovascular System for the repair of post DCB-angioplasty dissections.
Receives: Device: Tack Endovascular System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

  2. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionMay 2019
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02802306
Sponsor's protocol ID
CA 0135
Acronym
TOBA III
Status last verified
Apr 2021
First submitted
13 Jun 2016
Last updated
5 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 32414527

Questions about this trial

What is this clinical trial studying?

A study testing Tack Endovascular System in people with Peripheral Arterial Disease, run by Philips Clinical & Medical Affairs Global at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany, Belgium, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Freedom from the occurrence of any new-onset major adverse event(s) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02802306, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.

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