This prospective, single-arm study evaluated patients with peripheral arterial disease (Rutherford clinical category 2-4) caused by lesions of the superficial femoral and popliteal arteries. Patients were treated with standard or Lutonix® drug-coated balloon angioplasty (physician discretion), and post-PTA dissections were treated with Tack placement.
The primary end points* were freedom from MAE and primary patency.
- Safety: No MAE at 30 days
- 79.3% 12-month primary patency
- 86.5% 12-month freedom from CD-TLR
- 92.1% of dissections were completely resolved (69.4% of patients had a dissection ≥ Grade C)
- Improvement in ABI, Rutherford Classification and Quality of Life measures
There were no fractures reported, and only one bailout stent was placed.
High patency rate (79.3%) and high freedom from CD-TLR (86.5%) position Tack to be a clinically important treatment option for focal dissection repair after balloon angioplasty.
Twelve-month results were presented at VIVA 2018 by Dr. William Gray and manuscript is pending publication.
Safety: 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
Efficacy: Primary patency defined as freedom from 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)
Lutonix® is a registered trademark of BD InterventionalThis prospective, single-arm study evaluated patients with peripheral arterial disease (Rutherford clinical category 2-4) caused by lesions of the superficial femoral and popliteal arteries. Patients were treated with standard, non drug-coated balloon angioplasty, and post-PTA dissections were treated with Tack placement.
The primary end points were core laboratory-adjudicated device technical success* and device safety**. Patients were followed up to twelve months after implantation.
- Tack implants were used in 130 patients with post-PTA dissections (74.0% ≥ grade C***)
- Absence of new-onset MAEs was achieved in 100% of patients at 30 days
- Technical success was achieved in 98.5% of patients
- K-M twelve-month patency: 76.4%
- Freedom from CD-TLR: 89.5%
Significant improvement from baseline was observed in Rutherford clinical category (82.8% with RCC 1 at twelve months) and ankle-brachial index (0.68 ± 0.18 to 0.94 ± 0.15; P < .0001).
- Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization
These twelve-month results were presented at LINC 2015 by Dr. Marc Bosiers and published in the Journal of Vascular Surgery.
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Additional twenty-four month follow-up data from Westküstenkliniken in Heide, Germany was analyzed and presented at the 2017 VEITHsymposium™ by Dr. Christian Wisgott.
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Single-center twenty-four month results:
- K-M six-month patency: 93.8%
- K-M twelve-month patency: 87.5%
- K-M twenty-four month patency: 87.5%
- No loss of patency from twelve to twenty-four months
*defined as the ability of the Tack implants to resolve post-PTA dissection, which was achieved when the dissection was no longer visible by angiography and acute arterial patency was maintained at the implant location
**composite of all new-onset major adverse events (MAEs), which were defined as device and arterial embolization, need for emergency surgical revascularization, amputation above the ankle, or clinically driven TLR through 30 days after the procedure.
***arterial dissections were classified using the NHLBI grading system and adjudicated by the core laboratory.This prospective, single-arm study evaluated patients with critical limb ischemia (88.6% Rutherford clinical category 5) and infrapopliteal lesions. Patients were treated with standard non drug-coated balloon angioplasty, and post-PTA dissections were treated with Tack placement.
The primary safety endpoint was a composite of major adverse limb events (MALE)* and perioperative death (POD) at 30 days. Other endpoints included: device success, procedure success, freedom from CD-TLR, primary patency, and changes in Rutherford category**. Patients were followed up to twelve months after implantation.
- Tacks were used in 32 patients with post-PTA dissections
- Freedom from MALE + POD was achieved in 100% of patients at 30 days
- Device success: 91.4%
- Procedural success: 97.1%
- K-M twelve-month patency: 78.4% by vessel, 77.4% by patient
- Freedom from CD-TLR: 93.5%
Significant (P <.0001) improvement from baseline was observed in Rutherford category (75% of patients improved 4 or 5 steps).
- Tack implant treatment of post-PTA dissection was safe and effective for treatment of BTK dissections and resulted in reasonable twelve-month patency and low rates of CD-TLR
Twelve-month results were presented at SCAI 2016 by Dr. Christian Wissgott and published in Catheterization and Cardiovascular Interventions.
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*MALE events included major amputation (amputation above the ankle) or re-intervention in the target limb.
**Device success was defined as the achievement of successful delivery and deployment of Tack implant(s) at the intended target site(s) and successful withdrawal of the delivery catheter. Procedure success was demonstrated vessel patency as reported by the physician (visual estimate) without the occurrence of MALE + POD on the date of procedure. Primary patency was defined as presence of a pulsatile Doppler signal in the treated artery, freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from major amputation (above the ankle). Primary patency was considered lost at the first occurrence of CD-TLR, major amputation or lack of an acceptable Doppler signal observed at the 1, 3, 6 or 12-month follow-up. In the per vessel analysis, CD-TLR and major amputation indicate lack of primary patency for all vessels within the patient. In the absence of CD-TLR and major amputation each vessel’s patency is determined by whether a Doppler signal was audible at 30 days, 3, 6 and 12 months.These studies provided preliminary data on the safety and feasibility of the use of Tack implants for managing post-PTA dissection. In the preclinical study, seven swine underwent superficial femoral artery stent and Tack implantation for microscopy at 28 days. The clinical study included 15 limbs that underwent revascularization for critical limb ischemia or claudication. Patients were followed up to twelve months after implantation.
- Reduction in % diameter stenosis with the Tack (16.8 ± 2.6%) compared with stents (46.4 ± 9.8%)
- Neointimal thickness and injury scores decreased with Tack implantation
- Acute technical success* with resolution of the post-PTA dissection in 100% of lesions
- No device related complications
- No major amputations
- twelve-month angiographic patency** was 83.3%
- Preclinical data suggest that the Tack device causes minimal vessel injury
- Clinical use of the Tack device to manage post-PTA dissection was safe and feasible in this early study and resulted in apposition of dissection flaps without stent placement
This data was published in the Journal of the American College of Cardiology: Cardiovascular Interventions.
* Technical success was defined as acute luminal patency at the conclusion of the revascularization procedure, with angiography demonstrating that the lumen of the artery at the location of implant remains patent.
**Restenosis was defined as ≥50% by angiography.
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