Intracranial aneurysms managed by parent artery reconstruction using Tubridge: Study protocol for a prospective, multicenter, post-market clinical trial

2020 ◽  
pp. 159101992097623
Author(s):  
Qiaowei Wu ◽  
Li Li ◽  
Qiuji Shao ◽  
Tianming Xu ◽  
Kaitao Chang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intracranial Aneurysms ◽  
Parent Artery ◽  
Reconstruction Technique ◽  
Long Term Outcomes ◽  
Complete Occlusion ◽  
Post Market ◽  
Occlusion Rate

Background As a new endovascular reconstruction technique, flow diverter (FD) shows excellent efficacy and safety for treatment of intracranial aneurysms. In a previous multicenter, randomized, controlled, pre-market study, Tubridge FD showed remarkably higher complete occlusion rate compared with traditional stent-assisted coiling. However, a nonsignificant higher complication rate in the Tubridge group was noted. Considering the learning curve, the safety, and long-term outcomes of Tubridge FD should be verified in new prospective, real world, multicenter, post-market trials. Methods This study is a prospective, multicenter, single-arm, post-market clinical trial that evaluates the safety and efficacy of Tubridge in the treatment of patients with intracranial aneurysms by reconstructing parent artery. We expect 200 participants who meet the inclusion and exclusion criteria to be included. Clinical information and angiographic results (Raymond–Roy grading scale, RRGS) will be recorded objectively. The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up. Secondary endpoints will include the adequate occlusion rate (RRGS 1 & 2) and the rate of major in-stent stenosis (>50%) at 12-month follow-up, technique success rate, changes of modified Rankin Scale before and after the procedure, the rate of aneurysm related disability, neurological mortality, and all-cause mortality within follow-up period. Discussion This post-market, prospective trial may offer more information on the safety and long-term outcomes of Tubridge FD. When the study is complete, the results may provide us a new strategy for the treatment of intracranial aneurysms. Trial registration: WHO-Chinese Clinical Trial Registry: ChiCTR2000032282.

scholarly journals Endovascular Parent Artery Occlusion for Intracranial Aneurysms is a Viable, Cost-Effective Alternative: An Institutional Experience from Northeast India

2021 ◽  
Vol 28 (2) ◽  
pp. 6
Author(s):  
Pranjal Phukan ◽  
Kalyan Sarma ◽  
Donboklang Lynser ◽  
Barun Kumar Sharma ◽  
Deb Kumar Baruah ◽  
...  
Keyword(s):  
Intracranial Aneurysm ◽  
Intracranial Aneurysms ◽  
Cerebral Aneurysms ◽  
Artery Occlusion ◽  
Parent Artery ◽  
Complete Occlusion ◽  
Parent Artery Occlusion ◽  
Long Term Follow Up

Purpose. Endovascular parent artery occlusion (PAO) may be an alternative approach for complex intracranial aneurysm with potentially life-threatening complications. Moreover, the long-term follow-up of the PAO for an intracranial aneurysm is reported sparingly, limited to the case series. It is therefore important to carry out more research on long-term follow-up of the implication of PAO of intracranial aneurysm. The aim of the study was to analyses our experience of PAO for intracranial aneurysms with emphasis on long-term follow-up.Materials and Methods. The data of patients treated with PAO for intracranial aneurysms were reviewed. The outcome was evaluated based on aneurysmal occlusion on immediate angiography, follow-up magnetic resonance angiography (MRA), and complications. The modified Rankin score (mRS) was used to evaluate the functional outcome during the last follow-up. The mean, range, and standard deviation were reported for other variables – the patient’s age, number, and percentage.Results. Endovascular treatment was performed in 178 patients including PAO in 18 patients. Of these 18 (eighteen) patients, there were 13 dissecting aneurysms, 4 mycotic aneurysms, and one traumatic aneurysm.10 (ten) patients underwent PAO for proximal intracranial artery aneurysm and 8 (eight) patients for distal cerebral aneurysms. Complete occlusion of the aneurysm was achieved in 16patients (88.89%) and retrograde filling of the aneurysm was seen in 2 (11.11%) patients. One patient had intraprocedural coil migration resulting in a major infarct with an mRS of 2. Another patient (5.56%) had recanalization of the aneurysm and presented with rupture and intracranial hemorrhage with an mRS score of 4. The mRS of the other 16 patients (88.89%) was zero.Conclusions. Endovascular PAO for cerebral aneurysms was highly feasible and achieved complete occlusion. The morbidity and mortality rates were at the long-term follow-up also acceptable with negligible complications.

Medina embolization device for the treatment of intracranial aneurysms: 18 months’ angiographic results

2018 ◽  
Vol 11 (5) ◽  
pp. 516-522 ◽  
Author(s):  
Idriss Haffaf ◽  
Frédéric Clarençon ◽  
Eimad Shotar ◽  
Claudia Rolla-Bigliani ◽  
Saskia Vande Perre ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Thromboembolic Complication ◽  
Detachable Coil ◽  
Mean Delay ◽  
Scale Scores ◽  
Long Term Follow Up ◽  
Occlusion Rate ◽  
Wide Neck

Background and purposeThe Medina embolization device (MED) is a new flow disruption device combining the design of a detachable coil with an intrasaccular flow disrupter. Safety and short-term angiographic effectiveness of this device have recently been reported. However, long-term angiographic results are lacking. We report herein the 18 months’ angiographic outcome in patients treated for a wide-neck intracranial aneurysm with the MED.Materials and methodsNineteen patients (17 female, mean age 50 years) with 20 wide-neck intracranial aneurysms (six ruptured; 14 unruptured) were treated by the MED between January 2015 and June 2016. Procedure-related complications were systematically recorded; discharge and 6–9 months' follow-up modified Rankin Scale scores were assessed. Angiographic mid-term and long-term follow-up were performed with a mean delay of 6.4±1.5 months (n=16 aneurysms) and 17.7±4.2 months (n=15 aneurysms), respectively. Occlusion rates were evaluated after the procedure and at the mid-term and long-term follow-up using the Roy-Raymond scale.ResultsEmbolization with the MED was feasible in all except two cases (2/20, 10%). One per-procedural perforation was recorded (1/20, 5%) and one MED deployment failed because of the aneurysm’s shape (1/20, 5%). Three cases of thromboembolic complications were observed (3/20, 15%). Only one thromboembolic complication was responsible for clinical sequelae. Grade A occlusion rate was 61% (11/18) after the procedure, 75% at 6 months' follow-up (12/16), and 80% (12/15) at long-term follow-up. Two cases (2/18, 11%) of recanalization at mid-term were documented angiographically. No recanalization occurred between the mid-term and long-term follow-up.ConclusionMED is a hybrid embolization device, combining properties of a conventional coil with those of an intrasaccular flow disrupter. Our series focusing on long-term angiographic follow-up shows a satisfactory long-term occlusion rate. Larger series with longer angiographic follow-up times are warranted to confirm these preliminary results.

scholarly journals Long-term outcomes of coil embolization of unruptured intracranial aneurysms

2018 ◽  
Vol 129 (6) ◽  
pp. 1492-1498 ◽  
Author(s):  
Masaomi Koyanagi ◽  
Akira Ishii ◽  
Hirotoshi Imamura ◽  
Tetsu Satow ◽  
Kazumichi Yoshida ◽  
...  
Keyword(s):  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Additional Treatment ◽  
Long Term Outcomes ◽  
Unruptured Intracranial Aneurysms ◽  
Risk Of Rupture ◽  
Long Term Follow Up ◽  
Multiple Stroke

OBJECTIVELong-term follow-up results of the treatment of unruptured intracranial aneurysms (UIAs) by means of coil embolization remain unclear. The aim of this study was to analyze the frequency of rupture, retreatment, stroke, and death in patients with coiled UIAs who were followed for up to 20 years at multiple stroke centers.METHODSThe authors retrospectively analyzed data from cases in which patients underwent coil embolization between 1995 and 2004 at 4 stroke centers. In collecting the late (≥ 1 year) follow-up data, postal questionnaires were used to assess whether patients had experienced rupture or retreatment of a coiled aneurysm or any stroke or had died.RESULTSOverall, 184 patients with 188 UIAs were included. The median follow-up period was 12 years (interquartile range 11–13 years, maximum 20 years). A total of 152 UIAs (81%) were followed for more than 10 years. The incidence of rupture was 2 in 2122 aneurysm-years (annual rupture rate 0.09%). Nine of the 188 patients with coiled UIAs (4.8%) underwent additional treatment. In 5 of these 9 cases, the first retreatment was performed more than 5 years after the initial treatment. Large aneurysms were significantly more likely to require retreatment. Nine strokes occurred over the 2122 aneurysm-years. Seventeen patients died in this cohort.CONCLUSIONSThis study demonstrates a low risk of rupture of coiled UIAs with long-term follow-up periods of up to 20 years. This suggests that coiling of UIAs could prevent rupture for a long period of time. However, large aneurysms might need to be followed for a longer time.

A phase III multicenter randomized clinical trial to compare cisplatin plus fluorouracil with or without docetaxel as the first-line induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma: Long-term outcomes update.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6032-6032
Author(s):  
Wang Fang FangZheng
Keyword(s):  
Clinical Trial ◽  
Nasopharyngeal Carcinoma ◽  
Induction Chemotherapy ◽  
Phase Iii ◽  
Karnofsky Performance Score ◽  
Long Term Outcomes ◽  
First Line ◽  
Grade 3

6032 Background: A phase III multicenter prospective randomized controlled trial was conducted to compare cisplatin plus 5-fluorourcil with or without docetaxel as first-line induction chemotherapy in the patients with locoregionally advanced nasopharyngeal carcinoma (LANPC). Here, we report on the long-term outcomes and late toxicities of the trial (NCT01536223). Methods: Patients with newly diagnosed LANPC, stage III-IV disease, Karnofsky performance score≥70, without metastasis were eligible and randomly assigned 1:1 to TPF versus PF for three cycles. The primary end point was progression-free survival; local control, OS and advent events were important key secondary end points. The Kaplan-Meier method and the log-rank test were used to conduct and compare the survival curves in this study. Results: Two hundred ninety-nine patients were enrolled. 276 patients (138 TPF and 138 PF) were evaluable. Baseline characteristics were well-balanced between two groups, and the median age was 48 (range, 18-60 years). The ORR rates after induction chemotherapy and chemoradiotherapy were 90.6% and 9797.8% in TPF group and 87.0% (P > 0.05) and 97.8% (P > 0.05), respectively. The median follow-up was 99 months. For all patients, the 5- and 8-year OS and PFS were 76.9% and 74.9%, 72.3% and 69.1%, respectively. PF was associated with a similar PFS versus TPF ( 5-year PFS of 72.4% versus 73.2%, P =.747), and an equivalent OS at 5 years ( 79.2% and 79.1%, P = 0.519). Treatment-related grade 3 to 4 advent events were less frequent with PF compared with TPF. Conclusions: With prolonged follow-up, the survival outcomes in the PF group were not non-inferiority to those in the TPF group, but grade 3 to 4 advent events were less frequent. Clinical trial information: NCT01536223.

scholarly journals Endovascular Treatment of Small Ruptured Intracranial Aneurysms (<5 mm)

2019 ◽  
Vol 30 (4) ◽  
pp. 817-826
Author(s):  
Fei Peng ◽  
Xin Feng ◽  
Xin Tong ◽  
Baorui Zhang ◽  
Luyao Wang ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Cox Proportional Hazards ◽  
Parent Artery ◽  
Parent Vessel ◽  
Fisher Grade ◽  
Wide Neck ◽  
Ruptured Intracranial Aneurysms

Abstract Purpose To investigate the long-term clinical and angiographic outcomes and their related predictors in endovascular treatment (EVT) of small (<5 mm) ruptured intracranial aneurysms (SRA). Methods The study retrospectively reviewed patients with SRAs who underwent EVT between September 2011 and December 2016 in two Chinese stroke centers. Medical charts and telephone call follow-up were used to identify the overall unfavorable clinical outcomes (OUCO, modified Rankin score ≤2) and any recanalization or retreatment. The independent predictors of OUCO and recanalization were studied using univariate and multivariate analyses. Multivariate Cox proportional hazards models were used to identify the predictors of retreatment. Results In this study 272 SRAs were included with a median follow-up period of 5.0 years (interquartile range 3.5–6.5 years) and 231 patients with over 1171 aneurysm-years were contacted. Among these, OUCO, recanalization, and retreatment occurred in 20 (7.4%), 24 (12.8%), and 11 (7.1%) patients, respectively. Aneurysms accompanied by parent vessel stenosis (AAPVS), high Hunt-Hess grade, high Fisher grade, and intraoperative thrombogenesis in the parent artery (ITPA) were the independent predictors of OUCO. A wide neck was found to be a predictor of recanalization. The 11 retreatments included 1 case of surgical clipping, 6 cases of coiling, and 4 cases of stent-assisted coiling. A wide neck and AAPVS were the related predictors. Conclusion The present study demonstrated relatively favorable clinical and angiographic outcomes in EVT of SRAs in long-term follow-up of up to 5 years. THE AAPVS, as a morphological indicator of the parent artery for both OUCO and retreatment, needs further validation.

scholarly journals Long-term occlusion results with SILK flow diversion in 28 aneurysms: Do recanalizations occur during follow-up?

2015 ◽  
Vol 21 (3) ◽  
pp. 300-310 ◽  
Author(s):  
Anastasios Mpotsaris ◽  
Martin Skalej ◽  
Oliver Beuing ◽  
Bernd Eckert ◽  
Daniel Behme ◽  
...  
Keyword(s):  
Prospective Study ◽  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Success Rates ◽  
Imaging Data ◽  
Complete Occlusion ◽  
Complex Aneurysms ◽  
Multicenter Prospective Study

Background and purpose The purpose of this article is to report on the long-term success rates of Silk flow-diverter (FD) treatment in a multicenter prospective study for the treatment of complex aneurysms. Methods Between May 2008 and January 2011, all consecutive patients featuring complex intracranial aneurysms eligible for FD treatment with the Silk in three neurovascular centers were included. Clinical and imaging data were assessed during hospitalization and follow-up. Results Five patients were initially asymptomatic, 20 patients showed various neurological symptoms. Twenty-eight FDs were implanted in 25 patients treating 28 aneurysms. The immediate procedure-related morbidity was 8% (two of 25), mortality 0%. One procedure-related death was observed during follow-up (in-stent thrombosis). Compared to the immediate result nearly two of three aneurysms improved during follow-up; all angiographically confirmed inflow changes took place within six months after treatment. Final anatomic outcome in 24 aneurysms of 22 patients comprised 14 (59%) with complete occlusion, seven (29%) with a neck remnant, two (8%) with residual filling <50%, none with residual filling >50% and one (4%) unchanged in comparison to its pretreatment status. Postinterventional recanalizations were seen in three of 13 (23%) aneurysms treated with FD alone; none were observed in 15 aneurysms treated with adjunctive coiling. Conclusion Anatomic presentation and location are key for successful FD treatment. The rate of successful occlusion increases during follow-up. Postinterventional monitoring for at least six months is paramount, as anatomic outcome is not reliably predictable and recanalizations may occur in initially completely occluded aneurysms.

scholarly journals Paclitaxel-coated Zilver PTX drug-eluting stent treatment does not result in increased long-term all-cause mortality compared to uncoated devices from Japan post-market surveillance study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Yokoi
Keyword(s):  
Real World ◽  
Drug Eluting Stent ◽  
Long Term Outcomes ◽  
Risk Of Mortality ◽  
All Cause Mortality ◽  
Post Market ◽  
Drug Eluting ◽  
Zilver Ptx

Abstract Purpose Favorable long-term outcomes with the Zilver PTX drug-eluting stent (DES) in treating patients with femoropopliteal lesions have been demonstrated. A multicenter, prospective, post-market surveillance study (PMS) in Japan evaluated this DES in a real-world patient population. Recently, meta-analysis that grouped both DES and drug-coated balloons (DCB) together indicated a higher incidence of late all-cause mortality for paclitaxel- based devices compared to uncoated balloon or bare-metal stent (BMS) at 2 years up to 5 years. To evaluate the long-term safety of the Zilver PTX DES, compared with BMS using Japan-PMS study. Methods The Japan DES PMS had no exclusion criteria and enrolled consecutive patients with symptomatic PAD involving the above-the-knee femoropopliteal arteries. Safety and effectiveness of the DES was evaluated in real-world patients with complex femoropopliteal artery lesions through 5 years. Follow-up in the study is complete. The concurrent Japan BMS PMS also had no exclusion criteria and enrolled consecutive patients with symptomatic PAD involving the above-the-knee femoropopliteal arteries. Patients who were enrolled in the BMS study but who also had a DES placed (n=18) were excluded from the current analysis. Follow-up in the BMS study was only required through 3 years and is complete. Results The Japan DES PMS enrolled 904 DES patients, and the Japan BMS PMS enrolled 190 BMS patients. In the DES group, there were 127 deaths through 3 years and 186deaths through 5 years. In the BMS group, there were 22 deaths through 3 years. Through 3 years, the risk of mortality was 15.7% for DES group and 15.3% for BMS group. Through 5 years, the risk of mortality was 25.8% for the DES group. There was no difference in mortality between the two groups (log-rank p=0.92).The Cox proportional hazards model revealed that CLI (p&lt;0.0001), age (p&lt;0.0001), gender (p=0.001), renal failure (p&lt;0.0001) were significantly associated with mortality. Hypercholesterolemia (p=0.004) was associated with lower risk of mortality. Treatment with Zilver PTX (p=0.49) was not associated with mortality. In the covariate analysis of paclitaxel dose, the significant factors were identical to the treatment analysis, and there was no association or trend of paclitaxel dose (p=0.07) with mortality. Conclusion Analyses of the paclitaxel-coated Zilver PTX DES utilizing patient-level data from the Japan PMS demonstrated no increase in long-term all-cause mortality. The 5-year results from this real-world, all-comers study continue to show positive long-term outcomes and demonstrate the benefit of the Zilver PTX DES across a broad patient population. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): COOK

GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device

2017 ◽  
Vol 10 (1) ◽  
pp. 83-87 ◽  
Author(s):  
Waleed Brinjikji ◽  
Arun P Amar ◽  
Josser E Delgado Almandoz ◽  
Orlando Diaz ◽  
Pascal Jabbour ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Perioperative Complications ◽  
Major Complication ◽  
Clinical Results ◽  
Ease Of Use ◽  
Complete Occlusion ◽  
Aneurysm Neck ◽  
Registration Number ◽  
Occlusion Rate

Background and purposeThe HydroSoft coil was developed as a finishing coil, ideally to be placed along the aneurysm neck to enhance intracranial aneurysm healing. The GEL THE NEC (Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil) multicenter registry was developed to assess the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. We report angiographic and clinical results of this prospective registry.Materials and methodsGEL THE NEC was performed at 27 centers in five countries. Patients aged 21–90 years with a ruptured or unruptured aneurysm 3–15 mm in size were eligible for enrollment. The following variables were obtained: demographics/comorbidities, aneurysm geometry, adjunctive devices used, proportion of patients in whom HydroSoft coils were successfully placed, and long-term angiographic outcomes (graded by an independent core laboratory using the Modified Raymond Scale), and procedure-related adverse events. Predictors of good angiographic outcome were studied using χ2 and t-tests.ResultsA total of 599 patients with 599 aneurysms were included in this study. HydroSoft coils were successfully deployed in 577 (96.4%) patients. Procedure-related major morbidity and mortality were 0.5% (3/599) and 1.3% (8/599), respectively. The most common perioperative complications were iatrogenic vasospasm (30/599, 5.0%), thromboemboli (27/599, 4.5%), and aneurysm perforation (16/599, 2.7%). At last angiographic follow-up (mean 9.0±6.3 months), the complete occlusion rate was 63.2% (280/442) and near complete occlusion rate was 25.2% (107/442). The core laboratory read recanalization rate was 10.8% (46/425) and the retreatment rate was 3.4% (20/599).ConclusionsEndovascular treatment of intracranial aneurysms with HydroSoft coils resulted in complete/near complete occlusion rates of 88% and a major complication rate of 1.8%.Trial registration numberNCT01000675.

Sign in / Sign up

Export Citation Format

Share Document