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

NCT02224209 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2014-11-17

No results posted yet for this study

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

Interventions

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%.

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%.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Zhongrong Miao, M.D. · Beijing Tian Tan Hospital, Capital Medical University

  • Yongjun Wang, M.D. · Beijing Tian Tan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-10-31
Completion
2017-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02224209 on ClinicalTrials.gov