Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries

George L. Adams, Michael Lichtenberg, Christian Wissgott, Andrej Schmidt, Trisha Tarra, Shannon Matricardi, Patrick J. Geraghty

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


Purpose: To report 24 month safety and efficacy of the Tack Endovascular System for treatment of post-percutaneous transluminal angioplasty (PTA) infrapopliteal dissections in patients with critical limb-threatening ischemia (CLTI). Materials and Methods: The Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study was a prospective, multicenter, single-arm evaluation of the Tack Endovascular system for post-PTA infrapopliteal dissection repair. Patients with Rutherford Clinical Category (RC) 3 to 5 and a post-PTA dissection(s) of the BTK arteries were enrolled. The 30 day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary effectiveness endpoint was a composite of MALE at 6 months and 30 day POD. Outcomes were assessed as observational endpoints at 24 months. Results: Tack-Optimized Balloon Angioplasty II BTK enrolled 233 patients; all patients had a post-PTA dissection(s) and received ≥1 Tack implant (range, 1–16). Mean age was 74.4±10.0 years and 67.4% were men. Most patients had CLTI (RC 3: 16.3%; RC 4/5: 83.7%). Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions and total occlusions were present in 118 (47.6%) lesions. Kaplan-Meier freedom from MALE at 24 months + POD at 30 days was 92.2% and 24 month freedom from clinically-driven target lesions revascularization was 73.6%. Kaplan-Meier target limb salvage was 95.7% and amputation-free survival was 75.4%. Improvements in functional status and quality of life were observed through 24 months. Conclusion: The TOBA II BTK study demonstrated sustained safety and efficacy through 24 months in patients treated for post-PTA dissection(s) of BTK lesions. Clinical Trial Registration: identifier NCT02942966.

Original languageEnglish
Pages (from-to)393-400
Number of pages8
JournalJournal of Endovascular Therapy
Issue number3
StatePublished - Jun 2023


  • balloon angioplasty
  • critical limb ischemia
  • dissection
  • infrapopliteal arteries
  • peripheral artery disease


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