Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial

Laird, John R.; Zeller, Thomas; Loewe, Christian; Chamberlin, Jack R.; Begg, Richard J.; Schneider, Peter A.; Nanjundappa, Aravinda; Bunch, Frank; Schultz, Scott; Harlin, Stuart A.; Lansky, Alexandra J.; Jaff, Michael R.

doi:10.1177/1526602817749242

Cited by 27 publications

(21 citation statements)

References 37 publications

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“…Importantly, stent fracture rates vary between different types of stents. For example, the 12-month fracture rates of 2 cohorts employing the same stent was 3.1% for lesions averaging 7.1 cm in the RESILIENT study (12) compared to 27.1% for lesions averaging 11.8 cm reported in the TIGRIS study BMS arm (13). The mean lesion length of 11.7 cm in our study cohort was similar to the latter study.…”

Section: Example Of Corresponding Index and Target Lesion Revascularisupporting

confidence: 80%

Lesion Revascularisation Subsequent to Femoropopliteal Spot Stenting Using the Multi-LOC Stent Delivery System

Sigl

Amendt

Waliszewski

et al. 2019

In Vivo

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Background/Aim: Restenosis and stent fractures are well-characterised treatment failures following femoropopliteal (FP) stent-based interventions. We aimed to determine patterns of restenosis and fracture rates following focal stenting of FP arteries. Patients and Methods: This retrospective study investigated angiographic patterns of restenosis and the occurrence of stent fractures following focal FP stenting with the multiple stent delivery system VascuFlex ® Multi-LOC. Results: We identified 10 patients with 10 (of 129) FP lesions (mean length 11.7±4.6 cm) and a total of 51 (of 646) Multi-LOC stents that underwent clinically driven target lesion revascularizations (TLR) after 11.5±9.2 months, due to symptomatic recurrence of stenosis. None of the Multi-LOC stents had fractured. No isolated instent restenosis (>50%) was observed. Median diameter lumen loss was significantly more pronounced at the interstent segments (27.0%) compared to in-stent segments (7.8%, p=0.023). Conclusion: No evidence of fracture or susceptibility to stent-related restenosis using Multi-LOC stents was observed. Focal FP stenting may be more effective when combined with strategies known to reduce restenosis in non-stented artery segments.

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Section: Example Of Corresponding Index and Target Lesion Revascularisupporting

confidence: 80%

Lesion Revascularisation Subsequent to Femoropopliteal Spot Stenting Using the Multi-LOC Stent Delivery System

Sigl

Amendt

Waliszewski

et al. 2019

In Vivo

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“…Given the impact of fracture on clinical outcomes, it is preferable to avoid the risk altogether and use a fracture-resistant stent like TIGRIS in highly mobile anatomical locations such as the distal SFA or popliteal artery. 7…”

Section: Discussionmentioning

confidence: 99%

“…3,4 A number of later-generation stents have demonstrated lower fracture rates in response to this major shortcoming of the early models. [5][6][7] More recently paclitaxel-eluting stents and drug-coated balloons (DCB) have also demonstrated efficacy in the femoropopliteal segment and have been widely adopted. [8][9][10][11][12] The broad availability of DCBs has led to a "leave nothing behind" approach in lower limb endovascular therapy.…”

Section: Introductionmentioning

confidence: 99%

Prospective Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm

et al. 2019

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Purpose: To prospectively evaluate the safety and efficacy of the TIGRIS Vascular Stent in the superficial femoral artery (SFA) and proximal popliteal artery within a treatment algorithm that reserved stent usage for more challenging patients. Materials and Methods: This prospective, single-center study enrolled 97 patients (mean age 68.7 years; 66 men) who were treated for 100 de novo or nonstented restenotic femoropopliteal lesions (≥70% stenosis) and had recoil or dissection after plain balloon predilation. The average lesion length was 5.6±2.3 cm (maximum 8 cm per protocol). The composite primary efficacy outcome was 12-month primary patency, defined as a peak systolic velocity ratio ≤2.5 at the stented target lesion on duplex ultrasound, and no clinically-driven reintervention within the stented segment. The primary safety outcome was freedom from device- and procedure-related target vessel revascularization, target limb major amputation (above the metatarsals), or death through 30 days. Secondary outcomes included secondary patency, clinically-driven target lesion revascularization (TLR), Rutherford category change relative to baseline, and binary restenosis of the target lesion. Results: All devices were successfully implanted with no device-related complications at the time of implant or within the 30-day postimplant window. The average stented length was 7.0±2.5 cm; no stent elongation was observed during deployment. One patient was lost to follow-up before 12 months and another died of an unrelated cause, leaving 95 patients (98 lesions) available for 12-month follow-up and 77 patients/lesions for the 24-month preliminary analysis. The binary primary and secondary patency rates at 12 months were 92.9% and 100%. The binary freedom from TLR was 94.9%. At 24 months, the Kaplan-Meier estimate of primary patency was 90.0%. Conclusion: This prospective study demonstrated that the TIGRIS Vascular Stent is a safe and effective device in a modern treatment algorithm that reserved bare stent use for postangioplasty dissection or recoil in distal femoropopliteal arteries.

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“…Sin embargo, al analizar la tasa de fractura sí que observaron diferencias estadísticamente significativas. El grupo del stent dual no registró ninguna fractura, mientras que en el grupo del stent de nitinol se demostró un 32,7% de fractura de stent, una diferencia estadísticamente significativa (16). Estos resultados coinciden con los obtenidos en nuestro estudio.…”

Section: Discussionunclassified

Traumatismo Por Proyectil De Arteria Poplítea

Bartolomé¹,

Sánchez²,

Herrero³

et al. 2019

Angiologia

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Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial

Abstract: The TIGRIS stent and LifeStent were similarly effective for the treatment of lesions in the SFA and PPA. The high flexibility and zero fracture rate associated with the TIGRIS stent make this device favorable for use in high-flexion arteries.

Cited by 27 publications

References 37 publications

Lesion Revascularisation Subsequent to Femoropopliteal Spot Stenting Using the Multi-LOC Stent Delivery System

Lesion Revascularisation Subsequent to Femoropopliteal Spot Stenting Using the Multi-LOC Stent Delivery System

Prospective Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm

Traumatismo Por Proyectil De Arteria Poplítea

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