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

NCT02802306 | Completed

• 1 other identifier: CA 0135
• Study Type: interventional
• Target: 201
• Locations: 4 countries
• Sites: 17

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.

Conditions

Peripheral Arterial Disease

Keywords

Angioplasty; Peripheral Artery Disease; PAD; Lesion; Claudication

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Tack Implant

EXPERIMENTAL

Implantation of a Tack implant using the Intact Vascular Tack Endovascular System for the repair of post DCB-angioplasty dissections.

Device: Tack Endovascular System

Interventions

Tack Endovascular System DEVICE

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

Also known as: Post-PTA Dissection Repair Implant, Tack Implant, Tack Dissection Repair Device

Tack Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (17)

University Hospital AKH Vienna

Vienna, Austria

Location

Imelda Hosptial

Bonheiden, Belgium

Location

A.Z. St. Blasius Hospital

Dendermonde, Belgium

Location

Karolinen-Hospital Klinik für Angiologie Arnsberg Clinic

Arnsberg, Germany

Location

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

Bad Krozingen, Germany

Location

Franziskus-Hospital Berlin

Berlin, Germany

Location

Medizinische Klinik II Fürst Stirum Klinik Bruchsal

Bruchsal, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

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

Hamburg, 20099, Germany

Location

Center for Cardiology & Vascular Intervention

Hamburg, Germany

Location

Westküstenklinikum Heide

Heide, Germany

Location

Herz und Gefäßzentrum im Klinikverbund Oberallgäu-Kempten

Immenstadt im Allgäu, Germany

Location

Klinikum Karlsbad Langensteinbach

Karlsbad, Germany

Location

Universitätsklinik Leipzig

Leipzig, Germany

Location

Universitätsmedizin Mainz II Medizinische Klinik und Poliklinik, Angiologie

Mainz, 55131, Germany

Location

Cantonal Hospital Lucerne Division of Angiology

Lucerne, Switzerland

Location

Ospedale Regionale di Lugano - Civico e Italiana Civico

Lugano, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32414527 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marianne Brodmann, MD

  Medical University Hospital Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 16, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BE (2); DE (12); CH (2)