Plaque Prolapse Prevention Carotid Artery Stenting (3PCAS)

NCT02665585 | Completed DMC

• 1 other identifier: 3PCAS
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present positive-control study is to analyze and compare the rate of off-table subclinical neurological events in two groups of patients submitted to carotid artery stenting (CAS) with two different kind of stents, a close-cell stent, and the new mesh-covered stent, so to verify if the new model of stent is effective in preventing postprocedural carotid plaque embolism.

Conditions

Cerebrovascular Disease

Keywords

carotid disease; stroke; stent; carotid stenting

Outcome Measures

Primary Outcomes (2)

• perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events clinically detectable.

  perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events clinically (TIA, stroke, permanent focal retinal artery occlusion, neurological death).

  intraoperative and up to 72 hours postoperatively

• perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events subclinically detectable.

  perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events subclinically detectable (by new DW-MRI lesions, ≥0.02 µg/L increase in S100β and/or ≥0.3 µg/L increase in NSE serum levels, ≥5 variation in postprocedural MiniMentalStateExaminationTest -MMSE score).

  intraoperative and up to 72 hours postoperatively

Secondary Outcomes (2)

• local (inguinal haemathoma, pseudoaneurysm formation, access vessel dissection or thrombosis) complications occurring during or after procedure.

  intraoperative and up to 72 hours postoperatively

• systemic complications occurring during or after procedure.

  intraoperative and up to 72 hours postoperatively

Study Arms (2)

C-Guard carotid stent

EXPERIMENTAL

Carotid stenting procedure by C-Guard stent implantation (InspireMD, Boston, MA, USA)

Procedure: Carotid stenting procedure by carotid stent implantation

Wallstent carotid stent

ACTIVE COMPARATOR

Carotid stenting procedure by Wallstent implantation (BostonScientific, Marlborough, MA, USA)

Procedure: Carotid stenting procedure by carotid stent implantation

Interventions

Carotid stenting procedure by carotid stent implantation PROCEDURE

Carotid stenting procedure by carotid stent implantation

C-Guard carotid stent; Wallstent carotid stent

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of a carotid stenosis ≥70% (NASCET evaluation criteria)
• no previous neurologic symptoms referred in the medical history
• absence of a previous brain ischemic lesion detected at DW-MRI

You may not qualify if:

• symptomatic carotid lesions
• previous ischemic brain lesions detected at DW-MRI
• inability to give consent
• significant contraindications to angiography,
• history of bleeding disorder,
• intracranial aneurysm or vascular malformation or hemorrhage,
• presence of intraluminal thrombus,
• poor entry points at the femoral artery,
• type 2-3 arch,
• bovine arch,
• severe aortic arch or ipsilateral ostial common carotid or brachiocephalic atherosclerosis,
• severe proximal common or distal internal carotid artery tortuosity,
• sharply angulated internal carotid artery,
• carotid string sign,
• circumferential calcification of carotid plaque,

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Laura Capoccia

Roma, 00161, Italy

Location

Related Publications (1)

• Capoccia L, Speziale F, Gazzetti M, Mariani P, Rizzo A, Mansour W, Sbarigia E, Fiorani P. Comparative study on carotid revascularization (endarterectomy vs stenting) using markers of cellular brain injury, neuropsychometric tests, and diffusion-weighted magnetic resonance imaging. J Vasc Surg. 2010 Mar;51(3):584-91, 591.e1-3; discussion 592. doi: 10.1016/j.jvs.2009.10.079. Epub 2010 Jan 4.

  PMID: 20045614 BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Francesco Speziale

  Chief and Full Professor Vascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "Sapienza" University of Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular and Endovascular Surgery Division, Department of Surgery

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 28, 2016
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)