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

NCT02224209 | Unknown Phase 4 DMC

• 1 other identifier: BTH-STEP
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Stenosis

Keywords

Carotid artery stenosis; High risk of hyperperfusion; Staged angioplasty; Routine single-stage stenting

Outcome Measures

Primary Outcomes (1)

• Cerebral hyperperfusion syndrome or cerebral hemorrhage

  * 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

  Within 30 days after CAS procedure or after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure.

Secondary Outcomes (9)

• Cerebral hyperperfusion syndrome or cerebral hemorrhage attributed to the target vessel within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure.

  within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure

• Acute success of the culprit vessel after stage-1 balloon angioplasty (Diameter stenosis < 70%).

  one year

• Cerebral hyperperfusion syndrome attributed to non-culprit vessels within 30 days to 1 year post procedure.

  one year

• Any intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 30 days to 1 year post procedure.

  one year

• Myocardial infarchtion (MI)

  one year

Study Arms (2)

Staged angioplasty

EXPERIMENTAL

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

Routine single-stage CAS

ACTIVE COMPARATOR

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

Interventions

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

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%.

Also known as: Abbott Stent System

Staged angioplasty

a balloon, stent DEVICE

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%.

Also known as: Abbott Stent System

Routine single-stage CAS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Cerebral CT perfusion imaging shows hypo-perfusion of the culprit vessel surrounding area, and
• DSA shows collateral circulation assessment \< 2, and
• 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

You may not qualify if:

• 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
• Unsuccessful placement of proximal or distal EPD during the procedure
• The target vessel angle≧45
• Participate in other clinical trials within three months

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• Mo D, Jia B, Shi H, Sun Y, Liu Q, Fan C, Deng J, Yuan J, Wu W, Jiang C, Zhang G, Du H, Ma N, Gao F, Sun X, Song L, Liu L, Peng G, Wang Y, Wang Y, Miao Z; STEP Study Group. Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion: a randomised clinical trial. Stroke Vasc Neurol. 2021 Mar;6(1):95-102. doi: 10.1136/svn-2020-000391. Epub 2020 Sep 24.

  PMID: 32973113 DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Stents

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Zhongrong Miao, M.D.

  Beijing Tian Tan Hospital, Capital Medical University

  STUDY DIRECTOR

• Yongjun Wang, M.D.

  Beijing Tian Tan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Intervention

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 25, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: September 1, 2017
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

CN (1)