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Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries (TOBA II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intact Vascular
ClinicalTrials.gov Identifier:
NCT02522884
First received: August 7, 2015
Last updated: May 9, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Peripheral Artery Disease Device: Tack Endovascular System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™

Resource links provided by NLM:


Further study details as provided by Intact Vascular:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 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 PSVR >2.5)


Secondary Outcome Measures:
  • Safety [ Time Frame: 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.


Enrollment: 213
Study Start Date: September 2015
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tack Implant
Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections.
Device: Tack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
Other Names:
  • Post-PTA Dissection Repair Implant
  • Tack Implant
  • Tack Dissection Repair Device

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02522884

  Show 37 Study Locations
Sponsors and Collaborators
Intact Vascular
Investigators
Principal Investigator: William A. Gray, MD Main Line Health/Lankenau Heart Institute
  More Information

Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT02522884     History of Changes
Other Study ID Numbers: CA 0119
Study First Received: August 7, 2015
Last Updated: May 9, 2017

Keywords provided by Intact Vascular:
Angioplasty
Peripheral Artery Disease
PAD
Lesion
Claudication

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on June 26, 2017