Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134557
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-11-05
Brief Title:
Therapeutic Effect of Blood Flow Reconstruction in IVADA
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
Analysis of the Therapeutic Effect of Blood Flow Reconstruction in the Treatment of Intracranial Dissection Aneurysm of Vertebral Artery
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IVADA Intracranial vertebral artery dissecting aneurysmsis one of the causes of subarachnoid hemorrhage or posterior circulation ischemia with high mortality and disability Current endovascular therapies for IVADA mainly include parent artery occlusion and endovascular blood reconstructive techniques The method of parent artery occlusion requires the sacrifice of one vertebral artery For the IVADA patients whose dissection involves PICAposterior inferior cerebellar arteryor anterior spinal artery severe ischemia even infarction of brain stem or cerebellar may be caused after parent artery occlusion they are usually irreversible damage so that method are rarely used nowEndovascular flood reconstructive techniques has become the mainstream including stent-alone or overlapping stent treatment stent-assisted coiling techniques single flow diverterFD stents or flow diverter assisted coil etcWith the improvements in stents flow diverter stent is efficient while they are associated with the risk of ischemia especially when vital arterial branches are covered It has been reported that FD techniques have certain advantages over traditional stents in the treatment of anterior circulating intracranial aneurysms In the treatment of posterior circulating aneurysms perioperative ischemic complications increase due to their influence on the blood flow of perforator arteries but there are few long-term observations at present Currently studies directly contrasting flow diverter and conventional stents in patients with IVADA are rare Therefore we performed the study to compare the safety and efficacy between flow diverters and conventional stents in IVADA patients undergoing endovascular therapy Stent-assisted coiling is the preferred option for most surgeons In additionIt is believed that dense packing is not necessary as long as the aneurysm neck is covered to isolate the dissection How everwhether it is really necessary to adjunct coiland if it is necessary what is the ideal packing density of coils there is no clear conclusion at presentThis study aimed to compare the safety and efficacy between flow diverter and conventional stents in patients with IVADA determine the ideal packing density of coils after FD stent placementand to observe the hemodynamic changes before and after the treatment of FD stent
Detailed Description:
This is a single-center retrospective and observational studyThis retrospective study was approved by the Medical Ethics Committee of Qilu Hospital of Shandong UniversityPatients diagnosed with IVADA who underwent endovascular blood reconstructive treatment in the institution from December 2011 to December 2022 were eligiblePatient age sexindex clinical presentation smoking drinking hypertension diabetes mellitus hyperlipidemia modified Rankin Scale mRS score aneurysm size and arterial branch anatomy were recorded Treatment details complications and angiographic and clinical outcomes were also recorded
The optimal treatment strategy was evaluated based on the patients neurological condition and comorbidities the angioarchitectural features of the aneurysm and the decision of the patient and their first degree relatives The conventional stents included Neuroform Stryker Neurovascular USA Enterprise Cordis Neurovascular USA and Solitaire ev3 USA stents and a low-profile visualized intraluminal support LVIS device MicroVention Terumo USA was used The flow diverters included Tubridge MicroPort NeuroTech China and Pipeline Medtronic USA devices All EVT procedures were performed via a femoral artery approach under general anesthesia An intravenous bolus of heparin 5000 IU was administered before the procedure Heparin was discontinued at the end of the procedure A standard 6F or 8F guide catheter was advanced into the subclavian artery proximal to the vertebral artery An intermediate catheter Navien Medtronic was then inserted into the V2 segment of the vertebral artery A stent microcatheter was used to access the true lumen of the aneurysm in the posterior cerebral artery through the guidewire For cases with additional coil insertion a coil microcatheter was placed in the aneurysm sac The stent was partially deployed to cover the aneurysm neck and temporarily jail the microcatheter after which the aneurysm was loosely or densely packed with detachable coils before the stent was completely deployed For long segmental lesions in which the aneurysm neck could not be covered completely with a single stent an additional stent was extended into the bridged segment If a single stent was not sufficient to alter the intra-aneurysmal hemodynamics overlapping stents were used to reconstruct the lesion
The anti-platelet drugs aspirin 100 mgday and clopidogrel 75 mgday were administered for at least 3 days prior to the procedure for patients with unruptured aneurysms All patients with ruptured aneurysm were given aspirin and clopidogrel 300mg by oral or nasal feeding before general anesthesia was administeredThe anti-platelet drugs aspirin 100 mgday and clopidogrel 75 mgday were administered for 3 months post-operatively followed by aspirin alone for 3 months Patients who had insufficient responses to aspirin or clopidogrel received a substitute antiplatelet agent ticagrelorThe diameter and length of the stent were chosen according to the dimensions of the affected parent vessel
The main complications during hospitalization were hemorrhage infarction or hydrocephalus requiring shunting Procedural complications included those that occurred intraoperatively or after EVT Periprocedural complications included those that occurred during hospitalization Clinical follow-up was performed via neurological examinations or telephone interviews Clinical outcomes were assigned based on the modified Rankin scale mRS score at the last follow-up 0-2 favorable outcome 3-6 unfavorable outcome Cerebral angiography was performed at 6 months after EVT to confirm aneurysm occlusion and the patency of the VAvertebral artery Aneurysm occlusions on immediate and final follow-up cerebral angiography were categorized as complete occlusion no filling of the contrast agent in the aneurysm sac or incomplete occlusion residual filling of the contrast agent in the aneurysm neck or sac
Imaging follow-up was performed using DSAdigital subtraction angiographyCTAComputer Tomographic AngiographyMRAMagnetic Resonance Angiography approximately 6 months after stenting The occlusion rate was evaluated using the OKellyMarotta OKM grading scale Recurrence was defined as an aneurysm that showed an increased percentage of contrast filling within the aneurysmal sac on follow-up angiography All imaging studies were evaluated independently by two neurointerventionalists with more than 5 years of experience Any disagreements were resolved by third neurointerventionalists with 10 years of experience Clinical outcomes were evaluated by determining the mRS score at follow-up visits or via telephone interviews
Using The R Programming Language softwarePropensity Score Matching 12 caliper value 005 to make it has no statistical differences between the two groups in baseline information The matched case data will be statistically analyzed by IBM SPSS Statistics270IBM Corp New York USA The one-sample Kolmogorov-Smirnov test was used to test the normality of the data distribution for continuous variables Continuous variables that conforming to a normal distribution are presented as mean and SD and do not conform to the normal distribution are expressed by the median 2575Categorical variables are presented as numbers frequency Continuous variables were compared using the Students t-test or Mann-Whitney U test as appropriate Categorical variables were compared using the chi-square test or Fishers exact test as appropriate Variables identified as potential predictors in univariate analysis p01 were included in binary logistic regression analysis forward to determine their status as independent predictors A p value of 005 was considered statistically significant
The optimal treatment strategy was evaluated based on the patients neurological condition and comorbidities the angioarchitectural features of the aneurysm and the decision of the patient and their first degree relatives The conventional stents included Neuroform Stryker Neurovascular USA Enterprise Cordis Neurovascular USA and Solitaire ev3 USA stents and a low-profile visualized intraluminal support LVIS device MicroVention Terumo USA was used The flow diverters included Tubridge MicroPort NeuroTech China and Pipeline Medtronic USA devices All EVT procedures were performed via a femoral artery approach under general anesthesia An intravenous bolus of heparin 5000 IU was administered before the procedure Heparin was discontinued at the end of the procedure A standard 6F or 8F guide catheter was advanced into the subclavian artery proximal to the vertebral artery An intermediate catheter Navien Medtronic was then inserted into the V2 segment of the vertebral artery A stent microcatheter was used to access the true lumen of the aneurysm in the posterior cerebral artery through the guidewire For cases with additional coil insertion a coil microcatheter was placed in the aneurysm sac The stent was partially deployed to cover the aneurysm neck and temporarily jail the microcatheter after which the aneurysm was loosely or densely packed with detachable coils before the stent was completely deployed For long segmental lesions in which the aneurysm neck could not be covered completely with a single stent an additional stent was extended into the bridged segment If a single stent was not sufficient to alter the intra-aneurysmal hemodynamics overlapping stents were used to reconstruct the lesion
The anti-platelet drugs aspirin 100 mgday and clopidogrel 75 mgday were administered for at least 3 days prior to the procedure for patients with unruptured aneurysms All patients with ruptured aneurysm were given aspirin and clopidogrel 300mg by oral or nasal feeding before general anesthesia was administeredThe anti-platelet drugs aspirin 100 mgday and clopidogrel 75 mgday were administered for 3 months post-operatively followed by aspirin alone for 3 months Patients who had insufficient responses to aspirin or clopidogrel received a substitute antiplatelet agent ticagrelorThe diameter and length of the stent were chosen according to the dimensions of the affected parent vessel
The main complications during hospitalization were hemorrhage infarction or hydrocephalus requiring shunting Procedural complications included those that occurred intraoperatively or after EVT Periprocedural complications included those that occurred during hospitalization Clinical follow-up was performed via neurological examinations or telephone interviews Clinical outcomes were assigned based on the modified Rankin scale mRS score at the last follow-up 0-2 favorable outcome 3-6 unfavorable outcome Cerebral angiography was performed at 6 months after EVT to confirm aneurysm occlusion and the patency of the VAvertebral artery Aneurysm occlusions on immediate and final follow-up cerebral angiography were categorized as complete occlusion no filling of the contrast agent in the aneurysm sac or incomplete occlusion residual filling of the contrast agent in the aneurysm neck or sac
Imaging follow-up was performed using DSAdigital subtraction angiographyCTAComputer Tomographic AngiographyMRAMagnetic Resonance Angiography approximately 6 months after stenting The occlusion rate was evaluated using the OKellyMarotta OKM grading scale Recurrence was defined as an aneurysm that showed an increased percentage of contrast filling within the aneurysmal sac on follow-up angiography All imaging studies were evaluated independently by two neurointerventionalists with more than 5 years of experience Any disagreements were resolved by third neurointerventionalists with 10 years of experience Clinical outcomes were evaluated by determining the mRS score at follow-up visits or via telephone interviews
Using The R Programming Language softwarePropensity Score Matching 12 caliper value 005 to make it has no statistical differences between the two groups in baseline information The matched case data will be statistically analyzed by IBM SPSS Statistics270IBM Corp New York USA The one-sample Kolmogorov-Smirnov test was used to test the normality of the data distribution for continuous variables Continuous variables that conforming to a normal distribution are presented as mean and SD and do not conform to the normal distribution are expressed by the median 2575Categorical variables are presented as numbers frequency Continuous variables were compared using the Students t-test or Mann-Whitney U test as appropriate Categorical variables were compared using the chi-square test or Fishers exact test as appropriate Variables identified as potential predictors in univariate analysis p01 were included in binary logistic regression analysis forward to determine their status as independent predictors A p value of 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None