iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study

Laird, John R.; Loja, Melissa N.; Zeller, Thomas; Niazi, Khusrow; Stone, David H.; Davé, Rajesh; Popma, Jeffrey J.; Jaff, Michael R.; Massaro, Joseph M.

doi:10.1016/j.jvir.2018.12.707

Cited by 13 publications

(15 citation statements)

References 25 publications

(63 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…At 3 years, AIOD patients treated with iCAST had a late clinical success rate of 72.4% and a freedom from TLR rate of 86.6%. 13 While these values are similar to those from the VBX FLEX trial, the two trials are not entirely comparable as they studied different patient populations. Only 5.8% of lesions treated in the iCARUS trial were TASC II C and there were no TASC II D lesions.…”

Section: Discussionmentioning

confidence: 63%

Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis

et al. 2020

View full text Add to dashboard Cite

Purpose: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions. Materials and Methods: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study ( ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR. Results: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (p<0.001). Of the 134 patients in the per protocol analysis, 107 (80%) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5% and assisted primary patency was 99.0%. The estimate of freedom from TLR per-lesion/vessel was 97.6% at 9 months and 91.2% at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6% and the 3-year estimate was 98.1%. The 3-year mean resting ABI was 0.93±0.19, an improvement of 0.17±0.26 from baseline (p<0.001). At 3 years, 82 patients (92.1%) improved ≥1 Rutherford category from baseline, and 77 patients (86.5%) maintained or improved upon their baseline functional status. Conclusion: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

show abstract

Section: Discussionmentioning

confidence: 63%

Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Of the prospective studies, three were pilot/feasibility studies performed in Europe and Oceania 26,28,32 and five were safety/efficacy trials performed in Europe, Oceania, and the United States. 14,25,27,[34][35][36] Of the retrospective studies, all were about the Advanta V12/iCast, three were performed in the United States, 29,33,37 two were in Europe, 30,31 and one was in Oceania. 38 The search identified nine published studies of the Advanta V12/iCast, two of the Viabahn VBX, one of the BeGraft, one of the LifeStream, and one of the JOSTENT.…”

Section: Resultsmentioning

confidence: 99%

“…[22][23][24] A total of 15 publications (14 studies) were ultimately included in this review and underwent data extraction (Table I). 14,[25][26][27][28][29][30][31][32][33][34][35][36][37][38] The complete dataset comprised patients treated in both the prospective trial and retrospective, real-world settings. Clinical trial setting conformed to strict inclusion and exclusion criteria of the protocol.…”

Section: Methodsmentioning

confidence: 99%

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Mwipatayi

Ouriel²,

Anwari

et al. 2020

Journal of Vascular Surgery

View full text Add to dashboard Cite

Objective: To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease. Methods: A systematic literature search was conducted to identify studies that investigated the use of CBE stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. Results: A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. Conclusions: CBE stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years.

show abstract

“…In the second case, the Atrium iCAST stent, a balloon expandable, stainless steel stent, with polytetrafluoroethylene (PTFE) covering was used. Both stents have been studied and FDA approved for use in peripheral vascular intervention 23,24 . These stents were utilized to correct the outflow graft obstruction due to the large caliber nature of the outflow graft.…”

Section: Discussionmentioning

confidence: 99%

Percutaneous treatment of left ventricular assist device outflow graft obstruction

Raza

Williams

Barry

et al. 2020

Cathet Cardio Intervent

View full text Add to dashboard Cite

Owing to the growing population with end stage heart failure, the use of left ventricular assist devices (LVADs) have become more widely accepted. Although survival has improved with newer generation LVADs, multiple complications including pump failure due to outflow graft obstruction have become more clinically relevant. Patients with this complication will present with heart failure symptoms due to inadequate unloading of the left ventricle by LVAD. This rare complication often requires open surgical repair in an already high-risk patient population. Alternative means to relieve the obstruction via percutaneous intervention has been described in rare cases. We present two unique cases of LVAD outflow graft obstruction which were percutaneously treated successfully. This article illustrates a potential treatment strategy for outflow graft obstruction with stenting as an alternative to open-heart surgery.

show abstract

iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study

Cited by 13 publications

References 25 publications

Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis

Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Percutaneous treatment of left ventricular assist device outflow graft obstruction

Contact Info

Product

Resources

About