We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries (TOBA II BTK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942966
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : July 28, 2021
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Philips Clinical & Medical Affairs Global

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE October 24, 2016
Results First Submitted Date  ICMJE April 2, 2021
Results First Posted Date  ICMJE July 28, 2021
Last Update Posted Date January 31, 2022
Actual Study Start Date  ICMJE February 8, 2017
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2021)
  • Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days [ Time Frame: 6 months ]
    Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
  • Safety - Number of Participants With MALE Plus POD at 30 Days [ Time Frame: 30 days ]
    Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
  • Efficacy - Freedom from MALE at 12 months [ Time Frame: 12 months ]
    Freedom from major adverse limb events (MALE) at 12 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis)
  • Efficacy - Freedom from POD at 30 days [ Time Frame: 30 days ]
    Freedom from perioperative death (POD) at 30 days
  • Safety - Freedom from MALE at 30 days [ Time Frame: 30 days ]
    Freedom from major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis)
  • Safety - Freedom from POD at 30 days [ Time Frame: 30 days ]
    Freedom from perioperative death (POD) at 30 days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2021)
  • Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months [ Time Frame: 6 months ]
    Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
  • Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months [ Time Frame: 6 months ]
    Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
  • Patency [ Time Frame: 12 months ]
    Target lesion(s) tacked segment(s) patency at 12 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 12 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
  • Target Limb Salvage [ Time Frame: 12 months ]
    Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 12 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
Official Title  ICMJE Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®
Brief 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 the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Tack Implant
Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee.
Intervention: Device: Tack Endovascular System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2019)
233
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2016)
232
Actual Study Completion Date  ICMJE January 10, 2022
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or non-pregnant females ≥ 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 (abstinence is acceptable) through the duration of the study
  • Subject 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 (ICF), an impartial witness may sign on behalf of the subject
  • Willing to comply with all required follow-up visits
  • Rutherford Classification 4 or 5.
  • WIfI Wound grade of 0, 1 or modified 2.
  • WIfI Foot Infection grade of 0 or 1.
  • Estimated life expectancy ≥1 year

Exclusion Criteria:

  • Is pregnant or refuses to use contraception through the duration of the study
  • Previous bypass graft in the target limb
  • Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure
  • Prior or planned above-ankle amputation or complete transmetatarsal amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridements)
  • WIfI Foot Infection grade 2 or 3
  • Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12,000/or febrile state
  • Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb less than 30 days prior to or planned for less than 30 days after the index procedure
  • Existing stent implant in the target vessel
  • Any other endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) less than 14 days prior to the index procedure or planned procedure less than 30 days after 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
  • WIfI Wound grade of 2 or 3.
  • Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
  • Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the Index Procedure
  • History of stroke or transient ischemic attack (TIA) less than 90 days prior to the Index Procedure
  • Currently on dialysis
  • Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
  • Participating in another ongoing investigational clinical trial in which the subject has not completed the primary endpoint(s)
  • 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
  • Known hypersensitivity or allergy to contrast agents that cannot be medically managed
  • Subject already enrolled into this study
  • Restenotic target lesion previously treated by means other than plain balloon angioplasty and/or less than 1 year prior to index procedure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Czechia,   Germany,   Hungary,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02942966
Other Study ID Numbers  ICMJE CA 0137
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Philips Clinical & Medical Affairs Global
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Philips Clinical & Medical Affairs Global
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick J. Geraghty, MD Washington University School of Medicine in St. Louis
Principal Investigator: George Adams, MD Rex Hospital
PRS Account Philips Clinical & Medical Affairs Global
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP