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Intracranial AneurysmNCT06134557

Therapeutic Effect of Blood Flow Reconstruction in IVADA

An observational study of Intracranial Aneurysm, run by Qilu Hospital of Shandong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
conventional stents
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteChina
Study dates
20 Dec 2023to 28 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • : Patients with SAH caused by trauma or other cerebrovascular diseases
  • 2: IVADA involves the extracranial vertebral artery
  • 3: Vertebrobasilar artery tortuosity and dilatation

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Qilu Hospital of Shandong University

    Jinan

    Tongfu Zhang, 18054566265, 532323616@qq.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
conventional stents
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional stentsProcedure or surgery

    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.

Study groups in NCT06134557
Study groupRoleWhat they receive
flow diverter stentssingle flow diverter(FD) stents or flow diverter assisted coil
Receives: Procedure: conventional stents
conventional stentsstent-alone or overlapping stent treatment ,stent-assisted coiling techniques
Receives: Procedure: conventional stents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complete aneurysm occlusion

    whether obtain complete aneurysm occlusion

    Measured: 6 months postoperatively

  2. Complications

    Ischemic or hemorrhagic complications

    Measured: during hospitalization(up to day 3) and post-discharge(12months post-discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start20 Dec 2023
  3. Primary completion31 Dec 2023
  4. Study completion28 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134557
Sponsor's protocol ID
KYLL-202306-092
Status last verified
Nov 2023
First submitted
5 Nov 2023
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Suzuki H, Kitagawa T, Gotoh M, Mitsueda-Ono T, Matsui M. Cervical Cord Infarction Caused by Dissection of the Intracranial Segment of the Vertebral Artery. Intern Med. 2018 Nov 15;57(22):3321-3324. doi: 10.2169/internalmedicine.0608-17. Epub 2018 Jul 6.

    PubMed 29984769
  • Debette S, Compter A, Labeyrie MA, Uyttenboogaart M, Metso TM, Majersik JJ, Goeggel-Simonetti B, Engelter ST, Pezzini A, Bijlenga P, Southerland AM, Naggara O, Bejot Y, Cole JW, Ducros A, Giacalone G, Schilling S, Reiner P, Sarikaya H, Welleweerd JC, Kappelle LJ, de Borst GJ, Bonati LH, Jung S, Thijs V, Martin JJ, Brandt T, Grond-Ginsbach C, Kloss M, Mizutani T, Minematsu K, Meschia JF, Pereira VM, Bersano A, Touze E, Lyrer PA, Leys D, Chabriat H, Markus HS, Worrall BB, Chabrier S, Baumgartner R, Stapf C, Tatlisumak T, Arnold M, Bousser MG. Epidemiology, pathophysiology, diagnosis, and management of intracranial artery dissection. Lancet Neurol. 2015 Jun;14(6):640-54. doi: 10.1016/S1474-4422(15)00009-5.

    PubMed 25987283
  • Mizutani T, Aruga T, Kirino T, Miki Y, Saito I, Tsuchida T. Recurrent subarachnoid hemorrhage from untreated ruptured vertebrobasilar dissecting aneurysms. Neurosurgery. 1995 May;36(5):905-11; discussion 912-3. doi: 10.1227/00006123-199505000-00003.

    PubMed 7791980
  • Gottesman RF, Sharma P, Robinson KA, Arnan M, Tsui M, Saber-Tehrani A, Newman-Toker DE. Imaging characteristics of symptomatic vertebral artery dissection: a systematic review. Neurologist. 2012 Sep;18(5):255-60. doi: 10.1097/NRL.0b013e3182675511.

    PubMed 22931729
  • Han M, Rim NJ, Lee JS, Kim SY, Choi JW. Feasibility of high-resolution MR imaging for the diagnosis of intracranial vertebrobasilar artery dissection. Eur Radiol. 2014 Dec;24(12):3017-24. doi: 10.1007/s00330-014-3296-5. Epub 2014 Jul 14.

    PubMed 25017728
  • Zang YZ, Wang ZG, Wang CW, Zhang Y, Ding X, Wang XF. [Clinical analysis of endovascular strategies in the treatment of vertebrobasilar dissecting aneurysms]. Zhonghua Yi Xue Za Zhi. 2016 Nov 8;96(41):3329-3332. doi: 10.3760/cma.j.issn.0376-2491.2016.41.011. Chinese.

    PubMed 27852380
  • Kim BM, Shin YS, Baik MW, Lee DH, Jeon P, Baik SK, Lee TH, Kang DH, Suh SI, Byun JS, Jung JY, Kwon K, Kim DJ, Park KY, Kim BS, Park JC, Kim SR, Kim YW, Kim H, Jo K, Yoon CH, Kim YS. Pipeline Embolization Device for Large/Giant or Fusiform Aneurysms: An Initial Multi-Center Experience in Korea. Neurointervention. 2016 Mar;11(1):10-7. doi: 10.5469/neuroint.2016.11.1.10. Epub 2016 Mar 3.

    PubMed 26958407
  • Acke F, Acou M, Hemelsoet D. Basilar artery dissection. Acta Neurol Belg. 2011 Dec;111(4):376. No abstract available.

    PubMed 22368989
  • Conforto AB. Challenges in diagnosis and treatment of cervico-cephalic arterial dissections. Arq Neuropsiquiatr. 2016 Apr;74(4):273-4. doi: 10.1590/0004-282X20160039. No abstract available.

    PubMed 27096998
  • Choi JW, Han DH, Kang KD, Jung HY, Renshaw PF. Aerobic exercise and attention deficit hyperactivity disorder: brain research. Med Sci Sports Exerc. 2015 Jan;47(1):33-9. doi: 10.1249/MSS.0000000000000373.

    PubMed 24824770
  • Wang Y, Cui L, Ji X, Dong Q, Zeng J, Wang Y, Zhou Y, Zhao X, Wang C, Liu L, Nguyen-Huynh MN, Claiborne Johnston S, Wong L, Li H; China National Stroke Registry Investigators. The China National Stroke Registry for patients with acute cerebrovascular events: design, rationale, and baseline patient characteristics. Int J Stroke. 2011 Aug;6(4):355-61. doi: 10.1111/j.1747-4949.2011.00584.x. Epub 2011 Feb 17.

    PubMed 21609414
  • Bejot Y, Daubail B, Debette S, Durier J, Giroud M. Incidence and outcome of cerebrovascular events related to cervical artery dissection: the Dijon Stroke Registry. Int J Stroke. 2014 Oct;9(7):879-82. doi: 10.1111/ijs.12154. Epub 2013 Oct 22.

    PubMed 24148660
  • Kapsalaki EZ, Rountas CD, Fountas KN. The Role of 3 Tesla MRA in the Detection of Intracranial Aneurysms. Int J Vasc Med. 2012;2012:792834. doi: 10.1155/2012/792834. Epub 2012 Jan 16.

    PubMed 22292121
  • Balik V, Yamada Y, Talari S, Kei Y, Sano H, Suyama D, Kawase T, Takagi K, Takizawa K, Kato Y. State-of-art in surgical treatment of dissecting posterior circulation intracranial aneurysms. Neurosurg Rev. 2018 Jan;41(1):31-45. doi: 10.1007/s10143-016-0749-0. Epub 2016 May 24.

    PubMed 27215913
  • Darsaut TE, Findlay JM, Magro E, Kotowski M, Roy D, Weill A, Bojanowski MW, Chaalala C, Iancu D, Lesiuk H, Sinclair J, Scholtes F, Martin D, Chow MM, O'Kelly CJ, Wong JH, Butcher K, Fox AJ, Arthur AS, Guilbert F, Tian L, Chagnon M, Nolet S, Gevry G, Raymond J. Surgical clipping or endovascular coiling for unruptured intracranial aneurysms: a pragmatic randomised trial. J Neurol Neurosurg Psychiatry. 2017 Aug;88(8):663-668. doi: 10.1136/jnnp-2016-315433. Epub 2017 Jun 20.

    PubMed 28634280

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tongfu Zhang (0086-18054566265, 532323616@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete aneurysm occlusion (time frame: 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06134557, which also lists 51 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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