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

• 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: Philips Clinical & Medical Affairs Global
• Information provided by (Responsible Party): Philips Clinical & Medical Affairs Global

Tracking Information

• First Submitted Date: October 20, 2016
• First Posted Date: October 24, 2016
• Results First Submitted Date: April 2, 2021
• Results First Posted Date: July 28, 2021
• Last Update Posted Date: January 31, 2022
• Actual Study Start Date: February 8, 2017
• Actual Primary Completion Date: July 11, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Peripheral Arterial Disease

Intervention

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

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 *

• Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.
• Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
• Adams GL, Lichtenberg M, Wissgott C, Schmidt A, Tarra T, Matricardi S, Geraghty PJ. Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries. J Endovasc Ther. 2022 Mar 30:15266028221083462. doi: 10.1177/15266028221083462. Online ahead of print.
• Geraghty PJ, Adams GL, Schmidt A, Lichtenberg M, Wissgott C, Armstrong EJ, Hertting K; TOBA II BTK investigators. Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK). J Endovasc Ther. 2020 Aug;27(4):626-636. doi: 10.1177/1526602820944402.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 2, 2019): 233
• Original Estimated Enrollment (submitted: October 21, 2016): 232
• Actual Study Completion Date: January 10, 2022
• Actual Primary Completion Date: July 11, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Czechia, Germany, Hungary, New Zealand, United States

Administrative Information

• NCT Number: NCT02942966
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Philips Clinical & Medical Affairs Global
• Original Responsible Party: Same as current
• Current Study Sponsor: Philips Clinical & Medical Affairs Global
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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