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

Peripheral Artery Disease Clinical Trial

— TOBA II  

Official title:

Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522884
• Other study ID #: CA 0119
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 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 a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: March 2020
• Est. primary completion date: May 2018
• 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 (abstinence is acceptable)

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 Informed Consent Form, 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 Artery Disease

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Hospital Graz	Graz
Austria	Hanusch Krankenhaus	Vienna
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht
United States	New Mexico Heart Institute, PA	Albuquerque	New Mexico
United States	Cedars Sinai Medical Center	Beverly Hills	California
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Holy Spirit Cardiology	Camp Hill	Pennsylvania
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Denver VA Medical Center	Denver	Colorado
United States	Alexian Brothers Medical Center Heart & Vascular Institute	Elk Grove Village	Illinois
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	Florida Research Network, LLC	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Adventist Midwest Health	LaGrange	Illinois
United States	St. Mary Medical Center	Langhorne	Pennsylvania
United States	Central Arkansas Veteran's Healthcare System	Little Rock	Arkansas
United States	North Dallas Research Associates	McKinney	Texas
United States	Mission Research Institute	New Braunfels	Texas
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	St. Joseph Hospital	Orange	California
United States	Einstein Medical Center Philadelphia	Philadelphia	Pennsylvania
United States	The Miriam Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	NC Heart and Vascular Research - WakeMed Raleigh	Raleigh	North Carolina
United States	North Central Heart	Sioux Falls	South Dakota
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	Metro Health Hospital	Wyoming	Michigan
United States	Yuma Regional Medical Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Countries where clinical trial is conducted

United States,  Austria,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months	Primary patency defined as freedom from Clinical Events Committee (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 peak systolic velocity ratio (PSVR) >2.5)	12 Months
Primary	Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 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.	30 Days