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Comparison of Staged Angioplasty and Routine Single-stage Stenting (CAS) in the Treatment of Carotid Artery Stenosis (STEP)

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ClinicalTrials.gov Identifier: NCT02224209
Recruitment Status : Unknown
Verified November 2014 by Zhongrong Miao, Beijing Tiantan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 25, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Zhongrong Miao, Beijing Tiantan Hospital

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of staged carotid angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with carotid artery stenosis at high hyperperfusion risk in peri-procedural period.

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Device: Abbott EPD systems (Accunet/Emboshield), a balloon, stent Device: a balloon, stent Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Staged Angioplasty v.s. Routine Single-stage Stenting (CAS) in the Treatment of Patients With Carotid Artery Stenosis at High Risk of Hyperperfusion (STEP): A Randomized Controlled Trial
Study Start Date : November 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Staged angioplasty

Using Abbott EPD systems (Accunet/Emboshield), a balloon, stent

Method of stage-1 angioplasty

The stent can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield) if distal filter cannot be used, balloon angioplasty can be performed under proximal protection device; Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis <70%.

Method of stage-2:

The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield); Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation; After the placement of stent, the angioplasty is a success when residual stenosis is <30%.

Device: Abbott EPD systems (Accunet/Emboshield), a balloon, stent

Standard method of endovascular interventional treatment:

Method of stage-1 angioplasty

  1. The stent can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield) if distal filter cannot be used, balloon angioplasty can be performed under proximal protection device;
  2. Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis <70%.

Method of stage-2:

  1. The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);
  2. Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;
  3. After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
Other Name: Abbott Stent System

Active Comparator: Routine single-stage CAS

Using a balloon, stent

Routine stenting procedure:

The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield); Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation; After the placement of stent, the angioplasty is a success when residual stenosis is <30%.

Device: a balloon, stent

Routine stenting procedure:

  1. The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);
  2. Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;
  3. After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
Other Name: Abbott Stent System




Primary Outcome Measures :
  1. Cerebral hyperperfusion syndrome or cerebral hemorrhage [ Time Frame: Within 30 days after CAS procedure or after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure. ]
    • Staged angioplasty arm: cerebral hyperperfusion syndrome or cerebral hemorrhage within 30 days after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure.
    • Regular single-stage CAS arm: cerebral hyperperfusion syndrome or cerebral hemorrhage within 30 days after CAS procedure


Secondary Outcome Measures :
  1. Cerebral hyperperfusion syndrome or cerebral hemorrhage attributed to the target vessel within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure. [ Time Frame: within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure ]
  2. Acute success of the culprit vessel after stage-1 balloon angioplasty (Diameter stenosis < 70%). [ Time Frame: one year ]
  3. Cerebral hyperperfusion syndrome attributed to non-culprit vessels within 30 days to 1 year post procedure. [ Time Frame: one year ]
  4. Any intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 30 days to 1 year post procedure. [ Time Frame: one year ]
  5. Myocardial infarchtion (MI) [ Time Frame: one year ]
  6. Major non-stroke hemorrhage (eg. Epidural hemorrhage, intradural hemorrhage, or other major systemic bleedings) [ Time Frame: one year ]
  7. Death at 30 days post procedure [ Time Frame: one year ]
  8. Stoke resulting in deformity [ Time Frame: one year ]
  9. Any stroke or death [ Time Frame: one year ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be 40~80 years of age
  • Patient with symptomatic carotid stenosis (defined as stroke/TIA of the patient within 90 days while he/she is taking at least one antithrombotic drug or under other intervention on vascular risk factors like hypertension or hyperlipidemia)
  • DSA shows percent carotid stenosis≥90% (quantification of the stenosis according to NASCET method); or near occlusion
  • Angiogram shows insufficient collateral circulation in the culprit vessel surrounding area:

    1. Cerebral CT perfusion imaging shows hypo-perfusion of the culprit vessel surrounding area, and
    2. DSA shows collateral circulation assessment < 2, and
    3. MRI cerebral imaging shows hemodynamic ischemic lesion
  • CT perfusion imaging shows cerebral blood flow of the culprit side is of 20% lower than the other lateral brain
  • Lesion length at the narrowest part < 25mm

Note: Grading of angiographic collateral circulation

  • Grade 0: No collateral circulation in the area dominated by the culprit vessel
  • Grade 1: Slow collateral circulation in the surrounding areas, but filling defects exist
  • Grade 2: Fast collateral circulation, but some areas still have filling defects
  • Grade 3: Collateral circulation is slow, but complete filling can be seen in the vein at a late stage
  • Grade 4: Complete and fast collateral circulation, without any filling defect

Exclusion Criteria:

  • Diffusive stenosis of the cerebral artery
  • MRI cerebral imaging shows perforating artery occlusion
  • Cerebral hemorrhage at the culprit vessel surrounding area within 6 weeks; potential thrombus from the heart
  • Subsequent cerebral tumor, cerebral aneurysm, or arteriovenous abnormality
  • Known contraindication to heparin, aspirin, ticlopidine, a aesthetic, and contrast; blood hemoglobin < 10g/dl, blood platelet < 100000
  • Severe nerve dysfunction in the culprit vessel surrounding area after a cerebral infarction (mRS≥3)
  • INR > 1.5 (irreversible), uncorrectable bleeding risk factors, life expectancy < 1 year
  • Women in pregnant or breast feeding
  • Committee adjudicating the inclusion criteria finds the patient is unsuitable for the staged angioplasty for carotid artery stenosis
  • Unsuccessful placement of proximal or distal EPD during the procedure
  • The target vessel angle≧45
  • Participate in other clinical trials within three months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224209


Locations
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China, Beijing
Beijing Tian Tan Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100050
Contact: Yongjun Wang, M.D.    13911172565      
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Study Director: Zhongrong Miao, M.D. Beijing Tian Tan Hospital, Capital Medical University
Study Director: Yongjun Wang, M.D. Beijing Tian Tan Hospital

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Responsible Party: Zhongrong Miao, Director of Department of Intervention, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02224209     History of Changes
Other Study ID Numbers: BTH-STEP
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014

Keywords provided by Zhongrong Miao, Beijing Tiantan Hospital:
Carotid artery stenosis
High risk of hyperperfusion
Staged angioplasty
Routine single-stage stenting

Additional relevant MeSH terms:
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Constriction, Pathologic
Carotid Stenosis
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases