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Carotid StenosisESCALATENCT03737175

Endarterectomy vs Stenting in Chinese Asymptomatic Carotid Stenosis Patients

A study testing Carotid Artery Stenting and Carotid Endarterectomy in people with Carotid Stenosis, run by Xuanwu Hospital, Beijing at 6 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Carotid Stenosis
What is being tested?
Carotid Artery Stenting and Carotid Endarterectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
6 sitesChina
Study dates
30 Mar 2018to 1 Apr 2021
Phase
Interventional
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical Criteria
  • Age≥50 years，sex unlimited；
  • Asymptomatic carotid stenosis ，ie no transient ischemic attack、stroke or other related neurological symptom caused by carotid stenosis in the past 6 months.(Only the clinical manifestations of dizziness or mild headache are considered asymptomatic carotid stenosis.)；
  • The patient understands the trial objective，understands and accepts the duration of the study，is able and willing to comply with all requirements，including follow-up and evaluation of it, voluntarily participates in the study and signs Informed Consent Form.
  • Anatomy Criteria
  • Internal carotid artery independent disease.（ Involving or not involving adjacent common carotid arteries is permitted.）；
Show all 11Show fewer
  • Carotid stenosis satisfies one of the following criteria ：
  • Ultrasonography suggests stenosis ≥ 70%，or angiography showed stenosis ≥ 60%；
  • Ultrasonography suggests stenosis < 70%，but angiography or other examination showed stenosis in an unstable state；
  • Patients with bilateral carotid stenosis, the treatment time for target vessel contralateral vessels is required 30 days before enrollment or 30 days after completion of study procedure；
  • The stent can reach the site of lesion smoothly as expected.

Who cannot join

  • Clinical Criteria
  • Patients with progressive stroke in the past 3 months or recent (Within 7 days)， CT or MRI suggested that the lesion is large，and may be with the risk of hemorrhagic transformation；
  • Patients with anesthesia contraindications；
  • Serious ipsilateral stroke occurred in the past and may confuse the judgment of the study endpoint；
  • Patients with severe dementia；
  • Patients with spontaneous intracerebral hemorrhage in the past 12 months；
Show all 25Show fewer
  • Large size of cerebral infarction or myocardial infarction occurred within 30 days ；
  • Patients with large intracranial aneurysms (diameter> 5mm)，and cannot be treated in advance or contemporaneous；
  • Chronic total occlusion without obvious cerebral ischemia symptoms；
  • Hemoglobin <100 g/l， Platelet count <125×109/L， INR>1.5， Bleeding time > 1 min，patients with exceeding the upper limits of normal，or heparin-related thrombocytopenia；
  • Patients unable to perform normal angiographic evaluation or unsafe percutaneous puncture point；
  • Patients with neurologic disorder that caused transient or permanent neurological deficits within 2 years before the surgery and can not be identified with transient ischemic attack or stroke；
  • Patients with other cardiac emboli sources, such as left ventricular aneurysm, intraluminal filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, infective endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma；
  • Recent gastrointestinal bleeding and affects antiplatelet therapy；
  • Surgical contraindications or patients with high risk of surgery defined as having any of the following： It is known that two or more proximal or main coronary artery stenosis ≥70%, untreated or unable to pass； Ejection fraction <30% or New York Heart Association (NYHA) functional class III or higher； Unstable angina，ie angina at resting state and electrocardiogram changes； Currently waiting main organ transplants (ie heart, lung, liver, kidney), or are doing relevant evaluate； Malignant tumor or respiratory insufficiency, life expectancy < 5 years or forced expiratory volume at one second < 30% (predicted)； Dialysis-dependent renal failure； Poor control of diabetes, fasting blood glucose >22mmol/L and ketone body > +2； Need to perform other general anesthesia during the same period；
  • There may be one or more anatomical conditions affecting the normal operative approach in patients with contraindications for carotid endarterectomy operation； there may be one or more anatomic situations to increase the risk of adverse events in patients with high operative risk；including： Neck radiation therapy history； Radical neck surgery history； Inoperable lesions (ie more than C2 lesions)； Spinal brake - unable to bend neck, or kyphotic deformity； Symptomatic dissection of the carotid siphon below； Common carotid artery opening lesion；present tracheotomy； Contralateral recurrent laryngeal nerve paralysis； Previously performed ipsilateral carotid endarterectomy，intracranial or subclavian arterial bypass surgery； Contralateral carotid artery occlusion； Lesions series； Severe long segment calcification of the carotid artery； Inaccessible lesions by endoluminal methods (Severe distortion of the aortic arch branch, no suitable introduction of arteries, aortic arch anatomy special）；
  • Investigators consider the patient inappropriate to participate in this clinical trial；
  • Those who participated in clinical trials of other drugs or medical devices before the inclusion did not reach the end of the time limit.
  • Angiography criteria
  • Severe vascular tortuosity, or anatomical conditions may affect the safe locomotion of guide catheter, guide sheath or stent；
  • Patients with ipsilateral carotid artery stenting or having a graft；
  • Patients with severe or extensive arteriosclerosis, involving the aortic arch and the proximal common carotid artery, causing locomotion danger of guide catheter or guide sheath；
  • Carotid endarterectomy contraindications by angiography：severity of intracranial or extracranial arterial stenosis that exceeds target lesions; cerebrovascular arteriovenous malformations; or other contraindications;
  • Patients with contralateral carotid artery stenosis, are expected to be performed within 30 days of the perioperative period of the study；
  • Occlusion.

Trial locations and contacts

6 sites in 1 country.

YongQuan Gu YQ Gu, Prof. contact

+8615901598209

guyongquan@xwhosp.org

JianMing Guo JM Guo contact

+8613146369562

guojianming@aliyun.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Sino-Japanese Friendship Hospital

    Beijing, 100000

    Peng Liu P Liu, Prof., +8613701333388

    ZhiDong Ye ZD Ye, +8613910682488

    Not yet recruiting

  • Shanghai Changhai Hospital

    Shanghai, 200000

    ZhiQing Zhao ZQ Zhao, Prof., +8613301617866

    Recruiting

  • Shanghai ChangZheng Hospital

    Shanghai, 200000

    LeFeng Qu LF Qu, Prof., +8618616505267

    Not yet recruiting

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai, 200000

    DaQiao Guo DQ Guo, Prof., +8613801785258

    Recruiting

  • The first affiliated Hospital of Xi ' an Jiaotong University

    Xi'an, 710000

    JianLin Liu JL Liu, Prof., +8613709250539

    Recruiting

  • The first affiliated Hospital of Zhengzhou University

    Zhengzhou, 450000

    Zhen Li Z Li, Prof., +8618303710000

    Recruiting

Other trials in China

About this study

Official title: Endarterectomy vs Stenting in Chinese Asymptomatic Carotid Stenosis Patients: Prospective, Multiple Center, Randomized Controlled Trail

Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety.

Read the detailed description

Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety.Study Design is a prospective, multiple center, randomized controlled trail.600 cases enrollment predict，each group including carotid artery stenting and carotid endarterectomy 300 cases.Follow-up period of 2 years.

Being tested
Carotid Artery Stenting, Carotid Endarterectomy
Medical subject headings
Carotid Stenosis

What participants receive

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

  • Carotid Artery StentingProcedure or surgery

    Carotid Artery Stenting

  • Carotid EndarterectomyProcedure or surgery

    Carotid Endarterectomy

Study groups in NCT03737175
Study groupRoleWhat they receive
Carotid Artery Stenting groupExperimentalCarotid Artery Stenting
Receives: Procedure: Carotid Artery Stenting
Carotid Endarterectomy groupActive comparatorCarotid Endarterectomy
Receives: Procedure: Carotid Endarterectomy

What is being measured

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

  1. Incidence of composite endpoints of myocardial infarction, stroke, and any death

    Incidence of composite endpoints of myocardial infarction, stroke, and any death at 30 days follow up

    Measured: 30 days

Secondary outcomes (13)

  1. Surgery success rate

    Surgery success rate

    Measured: 1 day

  2. Rate of complications

    Rate of complications within 30 days, complications include：Cranial nerve and peripheral nerve injury, vascular injury, non cerebral hemorrhage, wound complications as neck incision or related to puncture site, and other (such as anesthesia) complications；

    Measured: 30 days

  3. Incidence of myocardial infarction

    Incidence of myocardial infarction at 30 days follow up;

    Measured: 30 days

  4. Incidence of Ipsilateral stroke

    Incidence of Ipsilateral stroke at 30 days follow up;

    Measured: 30 days

  5. Incidence of Bilateral stroke

    Incidence of Bilateral stroke at 30 days follow up；

    Measured: 30 days

  6. Incidence of ipsilateral stroke

    Incidence of ipsilateral stroke at 12 months follow up；

    Measured: 12 months

  7. Carotid restenosis rate

    Carotid restenosis rate at 12、24 months follow up；

    Measured: 12、24 months

  8. Incidence of target lesion revascularization

    Incidence of target lesion revascularization at 6、12、24 months follow up；

    Measured: 6、12、24 months

  9. Incidence of composite endpoints of myocardial infarction, stroke, and any death

    Incidence of composite endpoints of myocardial infarction, stroke, and any death at 6、12、24 months follow up；

    Measured: 6、12、24 months

  10. Incidence of major stroke and minor stroke

    Incidence of major stroke and minor stroke at 6、12、24 months follow up；

    Measured: 6、12、24 months

  11. Surgical time

    Surgical time

    Measured: Through hospital stay，an average of 10days

  12. Hospitalization days

    Hospitalization days

    Measured: Through hospital stay，an average of 10days

  13. Hospitalization fees

    Hospitalization fees

    Measured: Through hospital stay，an average of 10days

Timeline

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

  1. First posted9 Nov 2018
  2. Study start30 Mar 2018
  3. Primary completion1 May 2019 (estimated)
  4. Study completion1 Apr 2021 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03737175
Sponsor's protocol ID
china carotid
Acronym
ESCALATE
Status last verified
Nov 2018
First submitted
6 Nov 2018
Last updated
9 Nov 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. doi: 10.1016/S1474-4422(07)70274-0. Epub 2007 Nov 13.

    PubMed 17993293

  • North American Symptomatic Carotid Endarterectomy Trial Collaborators; Barnett HJM, Taylor DW, Haynes RB, Sackett DL, Peerless SJ, Ferguson GG, Fox AJ, Rankin RN, Hachinski VC, Wiebers DO, Eliasziw M. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991 Aug 15;325(7):445-53. doi: 10.1056/NEJM199108153250701.

    PubMed 1852179

  • MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. European Carotid Surgery Trialists' Collaborative Group. Lancet. 1991 May 25;337(8752):1235-43.

    PubMed 1674060

Questions about this trial

What is this clinical trial studying?

A study testing Carotid Artery Stenting and Carotid Endarterectomy in people with Carotid Stenosis, run by Xuanwu Hospital, Beijing at 6 sites 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 11 inclusion and 25 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 YongQuan Gu YQ Gu, Prof. (+8615901598209, guyongquan@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of composite endpoints of myocardial infarction, stroke, and any death (time frame: 30 days). 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 NCT03737175, which also lists 3 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 9 Nov 2018.

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