Carotid Artery Aneurysm Treatment Using CGuard Divert-And-Heal Strategy

NCT04434456 | Unknown

• 1 other identifier: C-HEAL
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Non-randomized, single arm, open label, academic observational study of CGuard MicroNet covered stent system use to achieve endovascular lumen reconstruction in carotid artery aneurysms with indications for treatment (enlarging and/or dissecting / symptomatic). Jagiellonian University Medical College research project.

Conditions

Carotid Artery Aneurysm

Outcome Measures

Primary Outcomes (1)

• Rate of successful aneurysm exclusion

  Successful aneurysm cavity exclusion and endovascular lumen reconstruction on routine, non-invasive CT angiography

  6 months

Secondary Outcomes (9)

• Rate of procedural success

  Peri-procedural

• Rate of In-hospital MACNE (major adverse cardiac and neurological events)

  48 hrs or until discharge

• MACNE at 30 days

  30 days

• Number of peri-procedural complications

  48 hrs or until discharge

• Rate of clinical efficacy at 6 months

  6 months

Study Arms (1)

CGuard stenting (interventional)

CGuard implantation in the carotid artery with aneurysm requiring intervention

Device: CGuard stent implantation

Interventions

CGuard stent implantation DEVICE

CGuard stent implantation in the carotid artery with symptomatic, dissecting or enlarging aneurysm

CGuard stenting (interventional)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 to 25 patients meeting inclusion and exclusion criteria and evaluated by Vascular Team to receive an endovascular treatment for carotid artery aneurysm

You may qualify if:

• Patients older than 18 years, eligible for endovascular carotid artery aneurysm treatment with Micronet covered stent per Vascular Team evaluation, according to local standards
• Written, informed consent to participate
• Agreement to attend protocol required (standard) follow up visits and examinations

You may not qualify if:

• Preferred treatment other than stenting (surgery or conservative treatment / observation) per Vascular Team evaluation
• Life expectancy \<1 year (e.g. active neoplastic disease).
• Chronic kidney disease with creatinine \> 3.0 mg/dL.
• Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure)
• Pregnancy (positive pregnancy test)
• Coagulopathy.
• History of uncontrolled contrast media intolerance
• Angiographic
• Carotid artery aneurysm confirmed on angiography - symptomatic, dissected or enlarging
• Aneurysm eligible for endovascular treatment per Vascular Team evaluation (according to current standards, guidelines and study center practice)
• Unsuccessful true lumen engagement
• Aneurysm neck anatomy precluding healthy-to-healthy coverage with stent
• Anatomic variants precluding stent implantation
• Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead

Study Sites (1)

Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Krakow, Maloplska, 31-202, Poland

RECRUITING

Study Officials

• Piotr Musialek, MD, DPhil

  The John Paul II Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Musialek, MD, DPhil

CONTACT

+48126142287; p.musialek@szpitaljp2.krakow.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 16, 2020
• Study Start: April 27, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)