scholarly journals Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months

2017 ◽  
Vol 24 (3) ◽  
pp. 342-348 ◽  
Author(s):  
John H. Rundback ◽  
Patrick Peeters ◽  
Jon C. George ◽  
Michael R. Jaff ◽  
Peter L. Faries
Keyword(s):  
Iliac Artery ◽  
Ankle Brachial Index ◽  
External Iliac Artery ◽  
Patient Characteristics ◽  
The United States ◽  
Target Lesion ◽  
Primary Patency ◽  
Specific Patient ◽  
Target Vessel Revascularization ◽  
Primary Stenting

Purpose: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Methods: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2–4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Results: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Conclusion: Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

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

2017 ◽  
Vol 25 (1) ◽  
pp. 68-78 ◽  
Author(s):  
John R. Laird ◽  
Thomas Zeller ◽  
Christian Loewe ◽  
Jack Chamberlin ◽  
Richard Begg ◽  
...  
Keyword(s):  
Clinical Success ◽  
Randomized Study ◽  
Ankle Brachial Index ◽  
The United States ◽  
Target Lesion ◽  
Primary Patency ◽  
Lesion Length ◽  
Stent Fracture ◽  
Fracture Rate ◽  
High Flexibility

Purpose: To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA). Methods: This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary efficacy endpoint was primary patency at 12 months. Secondary endpoints included target lesion revascularization (TLR) and stent fracture. Clinical success and quality of life were also assessed. Results: Mean lesion length (107.6 vs 117.9 mm, p=0.29), procedure success (99.5% vs 97.1%, p=0.17), and freedom from MAE (99.5% vs 100%, p>0.99) were similar for the TIGRIS and control groups, respectively. Likewise, there was no difference in primary patency at 12 months (60.6% vs 63.2%, p=0.73) or 24 months (56.3% vs 50.2%, p=0.60) or in TLR at the same time points (76.6% vs 80.6%, p=0.49; 70.5% vs 67.2%, p=0.85). There were no differences in the changes in Rutherford category or the ankle/brachial index through 24 months. The rate of stent fracture was lower for TIGRIS compared with LifeStent (0% vs 32.7%, p<0.001). Conclusion: 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.

scholarly journals Effectiveness and Long-term Outcomes of Different Crossing Strategies for the Endovascular Treatment of  Iliac Artery Chronic Total Occlusions

2020 ◽  
Author(s):  
Huan Zhang ◽  
Xiangtao Li ◽  
Luyuan Niu ◽  
Yaping Feng ◽  
Xiaoyun Luo ◽  
...  
Keyword(s):  
Iliac Artery ◽  
External Iliac Artery ◽  
Target Lesion ◽  
Primary Patency ◽  
Long Term Outcomes ◽  
Chronic Total Occlusions ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Antegrade Approach

Abstract Background: The iliac occlusive disease is usually treated with endovascular procedures in recent years. The effectiveness of different crossing approaches for these occlusions is not precisely known. We performed a retrospective study to explore the optimal crossing approach (antegrade versus retrograde) for iliac artery chronic total occlusions (CTOs) and to examine the long-term outcomes. Materials and Methods: We performed a study on 107 patients (116 iliac occlusive lesions, mean age 64.0±11.1, 88 men) who underwent an iliac CTO endovascular intervention attempted with the use of both crossing strategies but were managed with one final crossing approach between August 2012 and August 2018. Baseline data, procedural characteristics, and outcomes were described. A Cox proportional hazard model and Kaplan-Meier method were developed to assess the differences in the two crossing approaches in terms of the 1-year and 5-year primary patency rates, target lesion revascularization (TLR ) and major adverse limb events (MALEs ). Results: Common iliac artery (CIA ) lesions were more likely to be crossed successfully in the retrograde direction (6.8% for antegrade vs. 20.9% for retrograde, p=0.005), while lesions in the CIA/ external iliac artery (EIA ) were more prone to be crossed successfully in the antegrade direction (58.9% for antegrade vs. 39.5% for retrograde, p=0.016). There were no significant differences in the crossing approach for EIA lesions between the two groups. The two crossing approaches were associated with similar estimates of 1- and 5-year primary patency, TLR and MALE rates. Conclusion: The antegrade approach was associated with a higher rate of successful crossing in CIA/EIA CTO lesions, while the CIA-only CTOs were more likely to be crossed successfully with the retrograde approach.

scholarly journals Effectiveness and Long-term Outcomes of Different Crossing Strategies for the Endovascular Treatment of Iliac Artery Chronic Total Occlusions

2020 ◽  
Author(s):  
Huan Zhang ◽  
Xiangtao Li ◽  
Luyuan Niu ◽  
Yaping Feng ◽  
Xiaoyun Luo ◽  
...  
Keyword(s):  
Iliac Artery ◽  
External Iliac Artery ◽  
Target Lesion ◽  
Primary Patency ◽  
Long Term Outcomes ◽  
Chronic Total Occlusions ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Antegrade Approach

Abstract Background: The iliac occlusive disease is usually treated with endovascular procedures in recent years. The effectiveness of different crossing approaches for these occlusions is not precisely known. We performed a retrospective study to explore the optimal crossing approach (antegrade versus retrograde) for iliac artery chronic total occlusions (CTOs) and to examine the long-term outcomes. Materials and Methods: We performed a study on 107 patients (116 iliac occlusive lesions, mean age 64.0±11.1, 88 men) who underwent an iliac CTO endovascular intervention attempted with the use of both crossing strategies but were managed with one final crossing approach between August 2012 and August 2018. Baseline data, procedural characteristics, and outcomes were described. A Cox proportional hazard model and Kaplan-Meier method were developed to assess the differences in the two crossing approaches in terms of the 1-year and 5-year primary patency rates, target lesion revascularization (TLR ) and major adverse limb events (MALEs ). Results: Common iliac artery (CIA ) lesions were more likely to be crossed successfully in the retrograde direction (6.8% for antegrade vs. 20.9% for retrograde, p=0.005), while lesions in the CIA/ external iliac artery (EIA ) were more prone to be crossed successfully in the antegrade direction (58.9% for antegrade vs. 39.5% for retrograde, p=0.016). There were no significant differences in the crossing approach for EIA lesions between the two groups. The two crossing approaches were associated with similar estimates of 1- and 5-year primary patency, TLR and MALE rates. Conclusion: The antegrade approach was associated with a higher rate of successful crossing in CIA/EIA CTO lesions, while the CIA-only CTOs were more likely to be crossed successfully with the retrograde approach.

scholarly journals Effectiveness and Long-term Outcomes of Different Crossing Strategies for the Endovascular Treatment of Iliac Artery Chronic Total Occlusions

2020 ◽  
Author(s):  
Huan Zhang ◽  
Xiangtao Li ◽  
Luyuan Niu ◽  
Yaping Feng ◽  
Xiaoyun Luo ◽  
...  
Keyword(s):  
Iliac Artery ◽  
External Iliac Artery ◽  
Target Lesion ◽  
Primary Patency ◽  
Long Term Outcomes ◽  
Chronic Total Occlusions ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Antegrade Approach

Abstract Background: The iliac occlusive disease is usually treated with endovascular procedures in recent years. The effectiveness of different crossing approaches for these occlusions is not precisely known. We performed a retrospective study to explore the optimal crossing approach (antegrade versus retrograde) for iliac artery chronic total occlusions (CTOs) and to examine the long-term outcomes. Materials and Methods: We performed a study on 107 patients (116 iliac occlusive lesions, mean age 64.0±11.1, 88 men) who underwent an iliac CTO endovascular intervention attempted with the use of both crossing strategies but were managed with one final crossing approach between August 2012 and August 2018. Baseline data, procedural characteristics, and outcomes were described. A Cox proportional hazard model and Kaplan-Meier method were developed to assess the differences in the two crossing approaches in terms of the 1-year and 5-year primary patency rates, target lesion revascularization (TLR ) and major adverse limb events (MALEs ). Results: Common iliac artery (CIA ) lesions were more likely to be crossed successfully in the retrograde direction (6.8% for antegrade vs. 20.9% for retrograde, p=0.005), while lesions in the CIA/ external iliac artery (EIA ) were more prone to be crossed successfully in the antegrade direction (58.9% for antegrade vs. 39.5% for retrograde, p=0.016). There were no significant differences in the crossing approach for EIA lesions between the two groups. The two crossing approaches were associated with similar estimates of 1- and 5-year primary patency, TLR and MALE rates. Conclusion: The antegrade approach was associated with a higher rate of successful crossing in CIA/EIA CTO lesions, while the CIA-only CTOs were more likely to be crossed successfully with the retrograde approach.

scholarly journals Effectiveness and long-term outcomes of different crossing strategies for the endovascular treatment of iliac artery chronic Total occlusions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Huan Zhang ◽  
Xiangtao Li ◽  
Luyuan Niu ◽  
Yaping Feng ◽  
Xiaoyun Luo ◽  
...  
Keyword(s):  
Iliac Artery ◽  
External Iliac Artery ◽  
Target Lesion ◽  
Primary Patency ◽  
Long Term Outcomes ◽  
Chronic Total Occlusions ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Antegrade Approach

Abstract Background The iliac occlusive disease is usually treated with endovascular procedures in recent years. The effectiveness of different crossing approaches for these occlusions is not precisely known. We performed a retrospective study to explore the optimal crossing approach (antegrade versus retrograde) for iliac artery chronic total occlusions (CTOs) and to examine the long-term outcomes. Materials and methods We performed a study on 107 patients (116 iliac occlusive lesions, mean age 64.0 ± 11.1, 88 men) who underwent an iliac CTO endovascular intervention attempted with the use of both crossing strategies but were managed with one final crossing approach between August 2012 and August 2018. Baseline data, procedural characteristics, and outcomes were described. A Cox proportional hazard model and Kaplan-Meier method were developed to assess the differences in the two crossing approaches in terms of the 1-year and 5-year primary patency rates, target lesion revascularization (TLR) and major adverse limb events (MALEs). Results Common iliac artery (CIA) lesions were more likely to be crossed successfully in the retrograde direction (6.8% for antegrade vs. 20.9% for retrograde, p = 0.005), while lesions in the CIA/ external iliac artery (EIA) were more prone to be crossed successfully in the antegrade direction (58.9% for antegrade vs. 39.5% for retrograde, p = 0.016). There were no significant differences in the crossing approach for EIA lesions between the two groups. The two crossing approaches were associated with similar estimates of 1- and 5-year primary patency, TLR and MALE rates. Conclusion The antegrade approach was associated with a higher rate of successful crossing in CIA/EIA CTO lesions, while the CIA-only CTOs were more likely to be crossed successfully with the retrograde approach.

scholarly journals Effectiveness and Long-term Outcomes of Different Crossing Strategies for the Endovascular Treatment of Complex Iliac Artery Chronic Total Occlusions

2020 ◽  
Author(s):  
Huan Zhang ◽  
Xiangtao Li ◽  
Luyuan Niu ◽  
Yaping Feng ◽  
Xiaoyun Luo ◽  
...  
Keyword(s):  
Iliac Artery ◽  
External Iliac Artery ◽  
Target Lesion ◽  
Primary Patency ◽  
Long Term Outcomes ◽  
Chronic Total Occlusions ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Antegrade Approach

Abstract Purpose To explore the optimal crossing approach (antegrade versus retrograde) for iliac artery chronic total occlusions (CTOs) and to examine the long-term outcomes. Materials and Methods We performed a study on 107 patients (116 iliac occlusive lesions, mean age 64.0±11.1, 88 men) who underwent an iliac CTO endovascular intervention attempted with the use of both crossing strategies but were managed with one final crossing approach between August 2012 and August 2018. Baseline data, procedural characteristics, and outcomes were described. A Cox proportional hazard model and Kaplan-Meier method were developed to assess the differences in the two crossing approaches in terms of the 1-year and 5-year primary patency rates, TLR (target lesion revascularization) and MALEs (major adverse limb events). Results CIA (common iliac artery) lesions were more likely to be crossed successfully in the retrograde direction (6.8% for antegrade vs. 20.9% for retrograde, p=0.005), while lesions in the CIA/EIA (external iliac artery) were more prone to be crossed successfully in the antegrade direction (58.9% for antegrade vs. 39.5% for retrograde, p=0.016). Considering EIA lesions, there were no significant differences in the crossing approach between the two groups. The two crossing approaches were associated with similar estimates of 1- and 5-year primary patency, TLR and MALE rates. Conclusion The antegrade approach was associated with a higher rate of successful crossing in CIA/EIA CTO lesions, while the CIA-only CTOs were more likely to be crossed successfully with the retrograde approach.

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC)

VASA ◽  
2021 ◽  
pp. 1-7
Author(s):  
Tanja Böhme ◽  
Elias Noory ◽  
Ulrich Beschorner ◽  
Frederik Lerke ◽  
Andrej Schmidt ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Small Sample ◽  
Adverse Event Rate ◽  
Control Cohort ◽  
Procedural Success ◽  
Laser Atherectomy

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

scholarly journals Midterm Outcomes after Primary Stenting in Treatment of Atherosclerotic Iliac Arteries

2021 ◽  
Author(s):  
Mehmet Atay ◽  
Onur Saydam ◽  
Deniz Şerefli ◽  
Ayşen Yaprak Engin ◽  
Burçin Abud ◽  
...  
Keyword(s):  
Iliac Artery ◽  
External Iliac Artery ◽  
Limb Ischemia ◽  
Lesion Length ◽  
Covered Stents ◽  
Complication Rates ◽  
Iliac Arteries ◽  
Primary Stenting ◽  
Stent Diameter ◽  
Severe Calcification

IntroductionThe purpose of this study was to report the midterm outcomes of primary stenting of iliac arteries with additional factors which affect the outcome and to compare the results between patients with simple and complex aorta iliac occlusive disease (AOID).Material and methodsFrom January 2015 and March 2018, the study consisted of 103 lesions in 93 patients with common iliac artery (CIA) and/or external iliac artery (EIA) lesions which accompanied with severe claudication or critical limb ischemia. Balloon-expandable stents (BMS), self-expandable stents (SES) and covered stents (CS) were used to treat the lesions.ResultsLesions of 93 patients that were in CIA and/or EIA and treated with ET were included to the study (n=103). Seventy-one (68.9%) lesions were classified as simple AIOD group (TASCII A-B) while 32(31.1%) were classified as complex AIOD (TASCII C-D) group. In 72.8% of the lesions only mild calcification was detected while 27.2% lesions had moderate or severe calcification. Mean stent diameter for CIA position was 8.26±0.8mm and for EIA position was 7.52±0.8mm. Mean lesion length in patients treated with BMS were 52.5±21.0mm while SES were 63.6±28.3(p=0.03). Technical success was achieved in 101(98.1%) lesions. Significant differences in primary (93% vs 63%) and secondary (98% vs 82%) patency rates at 24 months were found between patients in simple and complex AIOD group (p<0.001 p=0.001)ConclusionsConclusion: In our study, it was found that the primary stenting in patients who had AIOD had satisfactory results with high immediate success, low complication rates and acceptable midterm outcomes.

Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Aljoscha Rastan ◽  
Marianne Brodmann ◽  
Tanja Böhme ◽  
Roland Macharzina ◽  
Elias Noory ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Primary Study ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Infrapopliteal Artery ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. Results: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone ( P =0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P =0.475), respectively. At 1 year, the TLR rates were 30% (n=10) versus 43% (n=12; P =0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P =0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P =0.618) in the DA+DCB group and the DCB group, respectively. Conclusions: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

Treatment of iliac atherosclerotic lesions using the balloon-expandable dynamic bare metal stent: One-year outcomes of the BIODYNAMIC single-center retrospective analysis

Vascular ◽  
2020 ◽  
pp. 170853812094542
Author(s):  
Giovanni F Torsello ◽  
Beatrix Doerr ◽  
Konstantinos Donas ◽  
Bärbel Berekoven ◽  
Giovanni B Torsello ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Iliac Artery ◽  
Common Iliac Artery ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Limb Amputation ◽  
Single Center ◽  
Atherosclerotic Lesions ◽  
Treatment Standard ◽  
Stent System

Objectives Endovascular therapy using balloon expandable stents has become the treatment standard for most iliac atherosclerotic lesions. We aimed to assess the safety and performance of the Dynamic stainless-steel balloon-expanding stent system in this location. Methods BIODYNAMIC is a retrospective single center study including consecutive patients with iliac lesions treated with the Dynamic stent system. Not included were implantations inside an endograft. The primary endpoint was freedom from major adverse limb events (MALE) at 12 months, defined as index limb amputation or target lesion revascularization (TLR). Secondary endpoints were procedure success, ankle brachial index (ABI) and Rutherford class change, mortality and freedom from TLR after 12 months. Results Within two years, 182 patients with 234 lesions in the common iliac artery were enrolled. Rutherford class 5 and 6 were present in 11.5% of patients, average stent diameter was 8.0 ± 0.5 mm and stented length 40.0 ± 15.3 mm. The primary endpoint was reached in 96.2% (225/234) of the cases, with six TLR (2.6%) and three target limb amputations (1.3%). Procedure success was obtained in all but three patients (98.4%). In paired analysis, ABI improved by 0.25 ± 0.21 from baseline to 0.90 ± 0.16 post-procedure and Rutherford class improved by −1.75 ± 1.53. There were four non-device–related deaths (2.2%). Freedom from TLR was 97%, 95.3%, 94% and 92.7% at 24, 36, 48 and 60 months, respectively. Conclusion The Dynamic balloon-expandable stent system proved to be safe and effective in a population with common iliac artery lesions.

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