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

NCT ID: NCT02802306

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tack Implant

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

Group Type: EXPERIMENTAL

Tack Endovascular System

Intervention Type: DEVICE

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

Interventions

Tack Endovascular System

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

Intervention Type: DEVICE

Other Intervention Names

Post-PTA Dissection Repair Implant; Tack Implant; Tack Dissection Repair Device

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Brodmann, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Hospital Graz

Locations

University Hospital AKH Vienna

Vienna, , Austria

Imelda Hosptial

Bonheiden, , Belgium

A.Z. St. Blasius Hospital

Dendermonde, , Belgium

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

Center for Cardiology & Vascular Intervention

Hamburg, , Germany

Westküstenklinikum Heide

Heide, , Germany

Herz und Gefäßzentrum im Klinikverbund Oberallgäu-Kempten

Immenstadt im Allgäu, , Germany

Klinikum Karlsbad Langensteinbach

Karlsbad, , Germany

Universitätsklinik Leipzig

Leipzig, , Germany

Universitätsmedizin Mainz II Medizinische Klinik und Poliklinik, Angiologie

Mainz, , Germany

Cantonal Hospital Lucerne Division of Angiology

Lucerne, , Switzerland

Ospedale Regionale di Lugano - Civico e Italiana Civico

Lugano, , Switzerland

Countries

Austria; Belgium; Germany; Switzerland

References

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.

Reference Type: DERIVED

PMID: 32414527 (View on PubMed)

Other Identifiers

CA 0135

Identifier Type: -

Identifier Source: org_study_id