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

Peripheral Arterial Disease Clinical Trial

— TOBA III  

Official title:

Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802306
• Other study ID #: CA 0135
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2020

Study information

• Verified date: April 2021
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: May 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Austria	University Hospital AKH Vienna	Wien
Belgium	Imelda Hosptial	Bonheiden
Belgium	A.Z. St. Blasius Hospital	Dendermonde
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	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
Switzerland	Cantonal Hospital Lucerne Division of Angiology	Lucerne
Switzerland	Ospedale Regionale di Lugano - Civico e Italiana Civico	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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