Ultra-small diameter coils for treatment of intracranial aneurysms

This study reports our initial clinical experience treating very small intracranial aneurysms using only Target® Nano™ coils. Retrospective angiographic and clinical analysis was performed on a non-randomized single arm registry of all intracranial aneurysms treated with only Target® Nano™ coils (1 mm and 1.5 mm diameter only) during a 12 month period at two academic hospitals. Fourteen patients with 14 intracranial aneurysms were treated. The maximum diameter of saccular aneurysms treated ranged from 1.5 to 3.5 mm; minimum aneurysm diameter was 1.1 to 2 mm. The immediate complete aneurysm occlusion rate was 86% (12/14), and a small residual within the aneurysm was seen in 14% (2/14) of cases. Packing density from coils ranged between 24% and 83% (mean 51%). The immediate complication rate was 0% (0/14). The angiographic/MR angiography follow-up period was 22 to 70 weeks (mean 37 weeks) with an overall complete occlusion rate of 9/11 (81%), recurrence in 18% (2/11), and lack of follow-up in three cases, two due to death during hospitalization and one procedure not yet due for imaging follow-up. Both patients who died presented with brain aneurysm ruptures prior to treatment. Both recurrences were retreated with repeat coiling procedures. Our initial results using only Target® Nano™ coils for the endovascular treatment of very small intracranial aneurysms have demonstrated initial good safety and efficacy profiles.

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Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: A systematic review

Interventional Neuroradiology ◽

10.1177/15910199211027991 ◽

2021 ◽

pp. 159101992110279

Author(s):

Muhammad Waqas ◽

Rimal H Dossani ◽

Modhi Alkhaldi ◽

Jocelyn Neveu ◽

Justin M Cappuzzo ◽

...

Keyword(s):

Systematic Review ◽

Intracranial Aneurysms ◽

Flow Diverter ◽

Complication Rates ◽

Mesh Terms ◽

Aneurysm Occlusion ◽

Occlusion Rate ◽

Layered Flow ◽

Comparative Safety

Introduction The Flow Redirection Endoluminal Device (FRED; MicroVention) is a dual-layered flow diverter used for the treatment of intracranial aneurysms. The objective of this systematic review was to compile device-related safety and effectiveness data. Methods The literature from January 1, 2013 to April 30, 2021 was searched for studies describing use of the FRED for intracranial aneurysm treatment irrespective of aneurysm location and morphology. The review included anterior and posterior circulation ruptured and unruptured saccular, fusiform or dissection, and blister aneurysms. MeSH terms related to “flow re-direction endoluminal device” and “FRED for aneurysms” were used. Data related to indication, complications, and rates of aneurysm occlusion were retrieved and analyzed. Results Twenty-two studies with 1729 intracranial aneurysms were included in this review. Overall reported morbidity was 3.9% (range 0–20%). Overall procedure-related mortality was 1.4% (range 0–6%). Complication rates fell into 5 categories: technical (3.6%), ischemic (3.8%), thrombotic or stenotic (6%), hemorrhagic (1.5%), and non-neurological (0.8%). The aneurysm occlusion rate between 0 and 3 months (reported in 11 studies) was 47.8%. The occlusion rate between 4 and 6 months (reported in 14 studies) was 73.8%. Occlusion rates continued to increase to 75.1% at 7–12 months (reported in 10 studies) and 86.6% for follow-up beyond 1 year (reported in 10 studies). Conclusion This review indicated that the FRED is a safe and effective for the treatment of intracranial aneurysms. Future studies should directly compare the FRED with other flow diverters for a better understanding of comparative safety and effectiveness among the different devices.

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Hemodynamic Analysis for Endovascular Treatment in Small Unruptured Intracranial Aneurysms: A Matched Comparison Study of Flow Diverter Versus LVIS

10.21203/rs.3.rs-146236/v1 ◽

2021 ◽

Author(s):

Jian Liu ◽

Wenqiang Li ◽

Yisen Zhang ◽

Kun Wang ◽

Xinjian Yang ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Flow Diverter ◽

Clinical Analysis ◽

Complete Occlusion ◽

Aneurysm Neck ◽

Unruptured Intracranial Aneurysms ◽

Key Factor ◽

Occlusion Rate ◽

Two Parameters

Abstract BackgroundWe compared the treatment of small unruptured intracranial aneurysms (UIAs) with flow diverter and LVIS assisted coiling to determine the effects of hemodynamic changes caused by different stent and coil packing in endovascular treatment.MethodsFifty-one UIAs in 51 patients treated with pipeline embolization device (PED) were included in this study, and defined as the PED group. We matched controls 1:1 and enrolled 51 UIAs who treated with LVIS stent, which defined as the LVIS group. Computational fluid dynamics were performed to assess hemodynamic alterations between PED and LVIS. Clinical analysis was also performed between these two groups after the match.ResultsThere was no difference in procedural complications between two groups (P=0.558). At the first angiographic follow-up, the complete occlusion rate was significantly higher in the LVIS group compared with that in the PED group (98.0% vs 82.4%, P = 0.027). However, during the further angiographic follow-up, the complete occlusion rate in PED group achieved 100%, which was higher than that in LVIS group (98.0%). Compared with the LVIS group after treatment, cases in PED group showed a higher value of velocity in the aneurysm (0.03 ± 0.09 vs 0.01 ± 0.01, P=0.037) and WSS on the aneurysm (2.32 ± 5.40 vs 0.33 ± 0.47, P=0.011). Consequently, the reduction ratios of these two parameters were also showed statistical differences. These parameters in LVIS group showed much higher reduction ratios. However, the reduction ratio of the velocity on the neck plane was comparable between two groups. ConclusionsBoth LVIS and PED were safe and effective for the treatment of small UIAs. However, LVIS-assisted coiling produced greater hemodynamic alterations in the aneurysm sac compared with PED. The hemodynamics in the aneurysm neck may be a key factor for aneurysm outcome.

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Hemodynamic analysis for endovascular treatment in small unruptured intracranial aneurysms: a matched comparison study of flow diverter versus LVIS

Chinese Neurosurgical Journal ◽

10.1186/s41016-021-00266-w ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Jian Liu ◽

Wenqiang Li ◽

Yisen Zhang ◽

Kun Wang ◽

Xinjian Yang ◽

...

Keyword(s):

Endovascular Treatment ◽

Intracranial Aneurysms ◽

Flow Diverter ◽

Clinical Analysis ◽

Complete Occlusion ◽

Aneurysm Neck ◽

Unruptured Intracranial Aneurysms ◽

Occlusion Rate ◽

Two Parameters

Abstract Background We compared the treatment of small unruptured intracranial aneurysms (UIAs) with flow diverter and LVIS-assisted coiling to determine the effects of hemodynamic changes caused by different stent and coil packing in endovascular treatment. Methods Fifty-one UIAs in 51 patients treated with pipeline embolization device (PED) were included in this study and defined as the PED group. We matched controls 1:1 and enrolled 51 UIAs who were treated with LVIS stent, which were defined as the LVIS group. Computational fluid dynamics were performed to assess hemodynamic alterations between PED and LVIS. Clinical analysis was also performed between these two groups after the match. Results There was no difference in procedural complications between the two groups (P = 0.558). At the first angiographic follow-up, the complete occlusion rate was significantly higher in the LVIS group compared with that in the PED group (98.0% vs. 82.4%, P = 0.027). However, during the further angiographic follow-up, the complete occlusion rate in the PED group achieved 100%, which was higher than that in the LVIS group (98.0%). Compared with the LVIS group after treatment, cases in the PED group showed a higher value of velocity in the aneurysm (0.03 ± 0.09 vs. 0.01 ± 0.01, P = 0.037) and WSS on the aneurysm (2.32 ± 5.40 vs. 0.33 ± 0.47, P = 0.011). Consequently, the reduction ratios of these two parameters also showed statistical differences. These parameters in the LVIS group showed much higher reduction ratios. However, the reduction ratio of the velocity on the neck plane was comparable between two groups. Conclusions Both LVIS and PED were safe and effective for the treatment of small UIAs. However, LVIS-assisted coiling produced greater hemodynamic alterations in the aneurysm sac compared with PED. The hemodynamics in the aneurysm neck may be a key factor for aneurysm outcome.

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Use of Coils in Conjunction With the Pipeline Embolization Device for Treatment of Intracranial Aneurysms

Neurosurgery ◽

10.1227/neu.0000000000000579 ◽

2014 ◽

Vol 76 (2) ◽

pp. 142-149 ◽

Cited By ~ 58

Author(s):

Ning Lin ◽

Adam M. Brouillard ◽

Chandan Krishna ◽

Maxim Mokin ◽

Sabareesh K. Natarajan ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Neurological Complications ◽

Controlled Study ◽

Group Differences ◽

Pipeline Embolization Device ◽

Complex Anatomy ◽

Risk Of Rupture ◽

Aneurysm Occlusion ◽

Occlusion Rate

ABSTRACT BACKGROUND: Coiling in conjunction with Pipeline embolization device (PED) placement could provide immediate dome protection and an intraaneurysmal scaffold to prevent device prolapse for intracranial aneurysms with high rupture risk and complex anatomy. OBJECTIVE: To report results after treatment of aneurysms with PED with coils (PED+coils group) or without (PED-only group) at a single-institution. METHODS: In this case-controlled study, records of patients who underwent PED treatment between 2011 and 2013 were retrospectively reviewed. RESULTS: Twenty-nine patients were treated with PED+coils and 75 with PED-only. No statistically significant between-group differences were found in terms of age, sex, aneurysm location, medical comorbidities, and length of follow-up. Aneurysms treated by PED+coils were larger (16.3 mm vs 12.4 mm, P = .02) and more likely to be ruptured (20.7% vs 1.3%, P = .001) or dissecting (34.5% vs 9.3%, P = .002). PED deployment was successful in all cases. At the latest follow-up (mean, 7.8 months), complete aneurysm occlusion was achieved in a higher proportion of the PED+coils group (93.1% vs 74.7%, P = .03). Device foreshortening/migration occurred in 4 patients in the PED-only group and none in the PED+coils group. Fewer patients required retreatment in the PED+coils group (3.4% vs 16.0%, P = .71). Rates of neurological complications (10.3% PED+coils vs 8.0% PED-only, P = .7) and favorable outcome (modified Rankin Scale score = 0-2; 93.1% PED+coils vs 94.7% PED-only, P = .6) were similar. CONCLUSION: PED+coils may be a safe and effective treatment for aneurysms with high risk of rupture (or rerupture) and complex anatomy. Coiling in conjunction with PED placement provided a higher aneurysm occlusion rate and reduced the need for retreatment.

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Predictors of incomplete aneurysm occlusion after treatment with the Pipeline Embolization Device: PREMIER trial 1 year analysis

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2021-018054 ◽

2021 ◽

pp. neurintsurg-2021-018054

Author(s):

Ricardo A Hanel ◽

Andre Monteiro ◽

Peter K Nelson ◽

Demetrius K Lopes ◽

David F Kallmes

Keyword(s):

Treatment Failure ◽

Intracranial Aneurysms ◽

Side Branch ◽

Maximum Diameter ◽

Complete Occlusion ◽

Unruptured Aneurysms ◽

Aneurysm Occlusion ◽

Incomplete Occlusion ◽

Flow Diverters

BackgroundFlow diverters have revolutionized the treatment of intracranial aneurysms. Nevertheless, some aneurysms fail to occlude with flow diversion. The Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device (PREMIER) was a prospective, multicenter and single-arm trial of small and medium wide-necked unruptured aneurysms. In the current study, we evaluate the predictors of treatment failure in the PREMIER cohort.MethodsWe analyzed PREMIER patients who had incomplete occlusion (Raymond-Roy >1) at 1 year angiographic follow-up and compared them with those who achieved Raymond-Roy 1, aiming to identify predictors of treatment failure.Results25 aneurysms demonstrated incomplete occlusion at 1 year. There was a median reduction of 0.9 mm (IQR 0.41–2.43) in maximum diameter between pre-procedure and 1 year measurements, with no aneurysmal hemorrhage. Patients with incomplete occlusion were significantly older than those with complete occlusion (p=0.011). Smoking (p=0.045) and C6 segment location (p=0.005) were significantly associated with complete occlusion, while location at V4 (p=0.01) and C7 (p=0.007) and involvement of a side branch (p<0.001) were significantly associated with incomplete occlusion. In multivariable logistic regression, significant predictors of incomplete occlusion were non-smoker status (adjusted OR 4.49, 95% CI 1.11 to 18.09; p=0.03) and side branch involvement (adjusted OR 11.68, 95% CI 3.84 to 35.50; p<0.0001), while C6 location had reduced odds of incomplete occlusion (adjusted OR 0.29, 95% CI 0.10 to 0.84; p=0.02).ConclusionsThe results of our study are consistent with previous retrospective series and warrant consideration for technique adaptations to achieve higher occlusion rates. Further follow-up is needed to assess progression of aneurysm occlusion and clinical behavior in these cases.

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Evaluation of the Accero Stent for Stent-Assisted Coiling of Unruptured Wide-Necked Intracranial Aneurysm Treatment with Short-Term Follow-Up

Journal of Clinical Medicine ◽

10.3390/jcm9092808 ◽

2020 ◽

Vol 9 (9) ◽

pp. 2808

Author(s):

Wojciech Poncyljusz ◽

Kinga Kubiak ◽

Leszek Sagan ◽

Bartosz Limanówka ◽

Katarzyna Kołaczyk

Keyword(s):

Subarachnoid Hemorrhage ◽

Intracranial Aneurysms ◽

Clinical Results ◽

Class I ◽

Unruptured Aneurysms ◽

Patient Demographics ◽

Stent Deformation ◽

Unruptured Intracranial Aneurysms ◽

Occlusion Rate

Background: Stent-assisted coiling is an effective method of treating intracranial aneurysms. The aim of the study was to assess the safety and efficacy of the new Accero stent for the treatment of intracranial aneurysms. Materials and Methods: It was a retrospective, single-center study. Eighteen unruptured intracranial aneurysms were treated using the stent-assisted coiling method with the Accero stent. Patient demographics, aneurysm characteristics, procedural parameters, grade of occlusion, complications, and clinical results were analyzed. Follow-up magnetic resonance (MR) was performed 6 months after intervention. Results: Seventeen patients with 18 incidental unruptured aneurysms were electively treated with coiling and the Accero stent. The aneurysms were located on internal carotid artery (ICA), middle cerebral artery (MCA) and basilar artery (BA). All stents were deployed successfully. Immediate complete occlusion rate Raymond-Roy occlusion classification (RROC) class I was achieved in 13 cases and class II in 4 cases. Complications occurred in 2/17 treatments and included guidewire stent perforation with subarachnoid hemorrhage (SAH) and stent deformation. Vascular spasm in the subarachnoid hemorrhage (SAH) patient subsided before discharge. Ninety days after intervention, the modified Rankin Scale (mRS) value was 0. RROC class I was observed in 88.23% of cases in follow-up. Conclusion: The Accero stent provides excellent support for coil mass. It constitutes an efficacious device with good initial occlusion rate for treating wide-necked unruptured intracranial aneurysms.

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

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-014110 ◽

2018 ◽

Vol 11 (5) ◽

pp. 516-522 ◽

Cited By ~ 3

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.

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Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-014204 ◽

2018 ◽

Vol 11 (4) ◽

pp. 396-399 ◽

Cited By ~ 16

Author(s):

Mario Martínez-Galdámez ◽

Saleh M Lamin ◽

Konstantinos G Lagios ◽

Thomas Liebig ◽

Elisa F Ciceri ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Technical Success ◽

First Line ◽

Post Procedure ◽

Safety Outcomes ◽

Registration Number ◽

Aneurysm Diameter ◽

Major Stroke

PurposeThe Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs.Materials and methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year.ResultsFifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment.ConclusionsOur 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs.Trial registration numberNCT02390037

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Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion

Therapeutic Advances in Neurological Disorders ◽

10.1177/1756286420967828 ◽

2020 ◽

Vol 13 ◽

pp. 175628642096782

Author(s):

Bin Luo ◽

Huibin Kang ◽

Hongqi Zhang ◽

Tianxiao Li ◽

Jianmin Liu ◽

...

Keyword(s):

Blood Flow ◽

Intracranial Aneurysms ◽

Registry Study ◽

Vessel Occlusion ◽

Clinical Trial Registration ◽

Pipeline Embolization Device ◽

Venous Phase ◽

Aneurysm Occlusion ◽

Occlusion Rate ◽

Stent Stenosis

Background and Purpose: The Pipeline Embolization Device (PED, Covidien/Medtronic) is widely used to treat intracranial aneurysms. This PED in China post-market multi-center registry study (PLUS) investigated safety and effectiveness of the PED for intracranial aneurysms in the Chinese population. Methods: This was a panoramic, consecutive, real-world cohort registry study. Patients treated with PED with or without coils between November 2014 and October 2019 at 14 centers in China were included, and those treated by parent vessel occlusion or other stents were excluded. Study outcomes included angiographic evaluation of aneurysm occlusion, complications, in-stent stenosis, and predictors of aneurysm occlusion. A central committee reviewed all imaging and endpoint events. Results: In total, 1171 patients with 1322 intracranial aneurysms were included. The total occlusion rate was 81.4% (787/967) at mean follow-up of 8.96 ± 7.50 months, with 77.1% (380/493) occlusion in the PED alone and 85.9% (407/474) in the PED plus coiling group. On multi-variate analysis, female sex, hyperlipidemia, vertebral aneurysms, PED plus coiling, and blood flow detained to venous phase were significant predictors of aneurysm occlusion. In posterior circulation cohort, there was no variable associated with aneurysm occlusion. In-stent stenosis predictors included current smoking and cerebral sclerosis/stenosis. Conclusion: In the largest series on PED of multi-center date of China, data suggest that treatment with the flow-diverting PED in intracranial aneurysms was efficacious. The treatment of PED combined coiling and blood flow detained to venous phase after PED implant were associated with aneurysmal occlusion. The occlusion rate of vertebral aneurysms was higher than other location aneurysms. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03831672.

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

Interventional Neuroradiology ◽

10.1177/1591019920976233 ◽

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.

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