Carotid Artery AneurysmC-HEALNCT04434456
Carotid Artery Aneurysm Treatment Using CGuard Divert-And-Heal Strategy
An observational study of Carotid Artery Aneurysm, run by John Paul II Hospital, Krakow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Aneurysm
- What is being tested?
- CGuard stent implantation
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 27 Apr 2020to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- 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)
Who cannot join
- 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.
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- History of uncontrolled contrast media intolerance
- Angiographic
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, Maloplska, 31-202
Piotr Musialek, Prof, +48126142287, p.musialek@szpitaljp2.krakow.pl
About this study
Official title: Prospective Observational Study of CGuard MicroNet Covered Stent System Use as a Flow Diverter in the Endovascular Exclusion of Carotid Artery Aneurysms. (CGuard Divert-and-HEAL C-HEAL)
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.
Read the detailed description
Carotid artery aneurysm (CAA) is a relatively infrequent, but significant clinical condition with numerous diagnostic and therapeutic implications. CAA affects laminal flow in the carotid artery implicating the risk of thrombus formation in the aneurysm cavity, and subsequent ischemic stroke from distal embolization. Another important clinical problem related to the CAA is a possible aneurysm dissection and rupture. Symptomatic CAA and increasing dimensions of CAA institute unquestioned indications for the CAA treatment.
Surgical carotid aneurysm repair bears a significant risk (periprocedural stroke, cranial nerve damage, carotid artery ligation). Therefore endovascular techniques of CAA exclusion were developed. Covered stents, stent-grafts, and combined stenting and aneurysm embolization with coils were applied. However, covered stents were demonstrated to increase the restenosis risk, and other complications such as CAA neck endo-leak.
Newer technique involves the flow diversion by implantation of stent in dense-structured stent (such as Wallstent) or stent-in-stent implantation. In this case a luminary flow dominates over aneurysm filling, which is limited by stent structure. Gradual thrombosis and occlusion of aneurysm cavity and healing of aneurysm follows.This method disadvantage was related to necessity of double stent load and increased restenosis risk (double metal layer).
These issues were addressed only recently by the double layer mesh stents that demonstrate natural flow diverting capabilities. CGuard Stent system is a self-expandable stent covered with PET mesh (MicroNet) that prevents plaque protrusion into the vessel lumen. In addition, in low flow conditions MicroNet can act as the flow diverter. These stents are routinely implanted in elevated risk plaques in high reference centers in Europe.
Several published observations indicate the CGuard stent also demonstrates flow-diverting capabilities, but the systematic observation of such application was not performed.
C-HEAL is a non-randomized, single arm, open label academic observational study of CGuard stent implantation in carotid arteries in patients with symptomatic, dissecting or enlarging carotid artery aneurysm. Procedures are performed according to the center routine, with application of proximal or distal embolic protection device (if feasible), and standard pharmacotherapy according to the current guidelines.
- Conditions
- Carotid Artery Aneurysm
- Being tested
- CGuard stent implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGuard stent implantationDevice
CGuard stent implantation in the carotid artery with symptomatic, dissecting or enlarging aneurysm
| Study group | Role | What they receive |
|---|---|---|
| CGuard stenting (interventional) | CGuard implantation in the carotid artery with aneurysm requiring intervention Receives: Device: CGuard stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful aneurysm exclusion
Successful aneurysm cavity exclusion and endovascular lumen reconstruction on routine, non-invasive CT angiography
Measured: 6 months
Secondary outcomes (9)
Rate of procedural success
Procedural success defined as: Technical success (successful MicroNet covered stent delivery and implantation with complete aneurysm necks coverage) and Clinical success (no complications)
Measured: Peri-procedural
Rate of In-hospital MACNE (major adverse cardiac and neurological events)
In-hospital MACNE (death, stroke, myocardial infarction)
Measured: 48 hrs or until discharge
MACNE at 30 days
MACNE at 30 days (death, stroke, myocardial infarction)
Measured: 30 days
Number of peri-procedural complications
Any complications occurring up to 48 hours post procedure
Measured: 48 hrs or until discharge
Rate of clinical efficacy at 6 months
Clinical efficacy defined as successful aneurysm exclusion and no procedure related complications
Measured: 6 months
Rate of clinical efficacy at 12 months
Clinical efficacy defined as successful aneurysm exclusion and no procedure related complications
Measured: 12 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the target vessel segment
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)
Measured: 6 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)
Measured: 12 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start27 Apr 2020
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Musialek, MD, DPhil, Principal investigator, The John Paul II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434456
- Sponsor's protocol ID
- C-HEAL
- Acronym
- C-HEAL
- Status last verified
- Aug 2020
- First submitted
- 8 Jun 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of CGuard MicroNet Covered Stent System Use as a Flow Diverter in the Endovascular Exclusion of Carotid Artery Aneurysms. (CGuard Divert-and-HEAL C-HEAL)
- ClinicalTrials.gov ID
- NCT04434456
- Acronym / sponsor ID
- C-HEAL / C-HEAL
- Conditions
- Carotid Artery Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Carotid artery aneurysm (CAA) is a relatively infrequent, but significant clinical condition with numerous diagnostic and therapeutic implications. CAA affects laminal flow in the carotid artery implicating the risk of thrombus formation in the aneurysm cavity, and subsequent ischemic stroke from distal embolization. Another important clinical problem related to the CAA is a possible aneurysm dissection and rupture. Symptomatic CAA and increasing dimensions of CAA institute unquestioned indications for the CAA treatment.
Surgical carotid aneurysm repair bears a significant risk (periprocedural stroke, cranial nerve damage, carotid artery ligation). Therefore endovascular techniques of CAA exclusion were developed. Covered stents, stent-grafts, and combined stenting and aneurysm embolization with coils were applied. However, covered stents were demonstrated to increase the restenosis risk, and other complications such as CAA neck endo-leak.
Newer technique involves the flow diversion by implantation of stent in dense-structured stent (such as Wallstent) or stent-in-stent implantation. In this case a luminary flow dominates over aneurysm filling, which is limited by stent structure. Gradual thrombosis and occlusion of aneurysm cavity and healing of aneurysm follows.This method disadvantage was related to necessity of double stent load and increased restenosis risk (double metal layer).
These issues were addressed only recently by the double layer mesh stents that demonstrate natural flow diverting capabilities. CGuard Stent system is a self-expandable stent covered with PET mesh (MicroNet) that prevents plaque protrusion into the vessel lumen. In addition, in low flow conditions MicroNet can act as the flow diverter. These stents are routinely implanted in elevated risk plaques in high reference centers in Europe.
Several published observations indicate the CGuard stent also demonstrates flow-diverting capabilities, but the systematic observation of such application was not performed.
C-HEAL is a non-randomized, single arm, open label academic observational study of CGuard stent implantation in carotid arteries in patients with symptomatic, dissecting or enlarging carotid artery aneurysm. Procedures are performed according to the center routine, with application of proximal or distal embolic protection device (if feasible), and standard pharmacotherapy according to the current guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGuard stenting (interventional) | – | Device: CGuard stent implantationCGuard implantation in the carotid artery with aneurysm requiring intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGuard stent implantationCGuard stent implantation in the carotid artery with symptomatic, dissecting or enlarging aneurysm | Device | CGuard stenting (interventional) |
Primary outcome
Rate of successful aneurysm exclusion
Time frame: 6 months
Successful aneurysm cavity exclusion and endovascular lumen reconstruction on routine, non-invasive CT angiography
9 secondary outcomes
Rate of procedural success
Time frame: Peri-procedural
Rate of In-hospital MACNE (major adverse cardiac and neurological events)
Time frame: 48 hrs or until discharge
MACNE at 30 days
Time frame: 30 days
Number of peri-procedural complications
Time frame: 48 hrs or until discharge
Rate of clinical efficacy at 6 months
Time frame: 6 months
Rate of clinical efficacy at 12 months
Time frame: 12 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the target vessel segment
Time frame: 6 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment
Time frame: 12 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Musialek, MD, DPhil principal investigator
The John Paul II Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Aneurysm, run by John Paul II Hospital, Krakow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Musialek, MD, DPhil (+48126142287, p.musialek@szpitaljp2.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful aneurysm exclusion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.