Therapeutic Effect of Blood Flow Reconstruction in IVADA

February 21, 2024 updated by: Qilu Hospital of Shandong University

Analysis of the Therapeutic Effect of Blood Flow Reconstruction in the Treatment of Intracranial Dissection Aneurysm of Vertebral Artery

IVADA (Intracranial vertebral artery dissecting aneurysms）is 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 PICA（posterior inferior cerebellar artery）or 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 now.Endovascular flood reconstructive techniques has become the mainstream, including stent-alone or overlapping stent treatment ,stent-assisted coiling techniques, single flow diverter(FD) stents or flow diverter assisted coil, etc.With 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 addition,It is believed that dense packing is not necessary as long as the aneurysm neck is covered to isolate the dissection. How ever,whether it is really necessary to adjunct coil,and if it is necessary, what is the ideal packing density of coils, there is no clear conclusion at present.This 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 placement,and to observe the hemodynamic changes before and after the treatment of FD stent.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, retrospective, and observational study.This retrospective study was approved by the Medical Ethics Committee of Qilu Hospital of Shandong University.Patients diagnosed with IVADA who underwent endovascular blood reconstructive treatment in the institution from December 2011 to December 2022 were eligible.Patient age, sex,index, 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 mg/day and clopidogrel 75 mg/day) 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 administered.The anti-platelet drugs (aspirin 100 mg/day and clopidogrel 75 mg/day) 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 (ticagrelor).The 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 VA（vertebral 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 DSA（digital subtraction angiography）、CTA（Computer Tomographic Angiography）、MRA（Magnetic Resonance Angiography） approximately 6 months after stenting. The occlusion rate was evaluated using the O'KellyMarotta (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 software,Propensity Score Matching 1：2 (caliper value 0.05), 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 Statistics27.0(IBM 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 (25%,75%).Categorical variables are presented as numbers (frequency). Continuous variables were compared using the Student's t-test or Mann-Whitney U test, as appropriate. Categorical variables were compared using the chi-square test or Fisher's exact test, as appropriate. Variables identified as potential predictors in univariate analysis (p<0.1) were included in binary logistic regression analysis (forward) to determine their status as independent predictors. A p value of <0.05 was considered statistically significant.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Jinan, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with IVADA who underwent endovascular blood reconstructive tratement in our institution

Description

Inclusion Criteria:

  1. Patients with asymptomatic or SAH symptoms of intracranial hypertension
  2. After a preliminary diagnosis of cerebrovascular CTA or MRA, DSA angiography confirmed IVADA
  3. IVADA involves intracranial segment of vertebral artery (V4 )

Exclusion Criteria:

  • : Patients with SAH caused by trauma or other cerebrovascular diseases

    2: IVADA involves the extracranial vertebral artery

    3: Vertebrobasilar artery tortuosity and dilatation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
flow diverter stents
single flow diverter(FD) stents or flow diverter assisted coil
Procedure: conventional stents
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 addition,It is believed that dense packing is not necessary as long as the aneurysm neck is covered to isolate the dissection. How ever,whether it is really necessary to adjunct coil,and if it is necesary, what is the ideal packing density of coils, there is no clear conclusion at present.This 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 placement,and to observe the hemodynamic changes before and after the treatment of FD stent.
conventional stents
stent-alone or overlapping stent treatment ,stent-assisted coiling techniques
Procedure: conventional stents
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 addition,It is believed that dense packing is not necessary as long as the aneurysm neck is covered to isolate the dissection. How ever,whether it is really necessary to adjunct coil,and if it is necesary, what is the ideal packing density of coils, there is no clear conclusion at present.This 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 placement,and to observe the hemodynamic changes before and after the treatment of FD stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete aneurysm occlusion
Time Frame: 6 months postoperatively
whether obtain complete aneurysm occlusion
6 months postoperatively
Complications
Time Frame: during hospitalization（up to day 3） and post-discharge（12months post-discharge）
Ischemic or hemorrhagic complications
during hospitalization（up to day 3） and post-discharge（12months post-discharge）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Study Chair: Yunyan Wang, Medical Ethics Committee of Qilu Hospital of Shandong University
  • Study Director: Weiying Zhong, Medical Ethics Committee of Qilu Hospital of Shandong University
  • Principal Investigator: Maogui li, Medical Ethics Committee of Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202306-092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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