Testing new neck artery stents designed to safely trap atherosclerotic plaque and heal the artery
| ISRCTN | ISRCTN12857948 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12857948 |
| Protocol serial number | N41/DBS/001562 |
| Sponsor | Jagiellonian University Medical College |
| Funder | Uniwersytet Jagielloński Collegium Medicum |
- Submission date
- 14/12/2025
- Registration date
- 18/12/2025
- Last edited
- 17/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stent healing, as assessed by strut coverage, is a key parameter for optimizing the duration of "double" antiplatelet therapy (DAPT) in patients after stent implantation. Data on the micronet stent healing are lacking.
The aim of this study is to evaluate the strut coverage of MicroNET-covered CGuard stents by optical coherence tomography (OCT) at 1-3 months after implantation.
Who can participate?
Consecutive patients implanted with the micronet-covered stent (CGuard) in the carotid artery, who have indication to another (staged) endovascular intervention performed at 1, 2, or 3 months after the index carotid artery treatment
What does the study involve?
The study involves assessment of stent strut coverage using intravascular Optical Coherence Tomography ("an intravascular light transducer camera") imaging. OCT is routinely used as the modality of choice to evaluate stents.
What are the possible benefits and risks of participating?
Patients may benefit from identifying lack of stent healing or strut malapposition; this may trigger appropriate treatment.
Possible risks are associated with target vessel cannulation and contrast injection. However, in the study patients, the vascular access, catheterisation and contrast are, anyway, indicated and performed for a concomitant endovascular intervention.
Where is the study run from?
The study is run from a university research center, experienced in carotid and other endovascular interventions and in OCT imaging. (Jagiellonian University, Poland)
When is the study starting and how long is it expected to run for?
The study started in November 2024 and is expected to run till 31 December 2026.
Who is funding the study?
The study is funded by a research grant from the Jagiellonian University (Poland)
Who is the main contact?
Piotr Musialek, MD DPhil
Jagiellonian University Professor of Cardiovascular Medicine
Contact information
Public, Scientific, Principal investigator
80 Pradnicka St
KRAKóW
31-202
Poland
 ORCID ID |
0000-0001-9300-4833 |
|---|---|
| Phone | +48 126143399 |
| pmusialek@szpitaljp2.krakow.pl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre prospective observational longitudinal study |
| Secondary study design | Cohort study |
| Scientific title | Healing Profile of the micronet-covered AtheRomA-isolating carotid stents Deployed for optimIsed Guard against cerebral embolisM: Optical Coherence Tomography Study |
| Study acronym | PARADIGM-OCT |
| Study objectives | To evaluate the strut coverage of MicroNET-covered CGuard stents by optical coherence tomography (OCT) at 1-3 months after implantation. |
| Ethics approval(s) |
Approved 20/11/2024, Bioethical Committee of the Jagiellonian University (Skawinska 8, Krakow, 31-066, Poland; +48 124332739; joanna.plucinska@uj.edu.pl), ref: 10726120286_2024 |
| Health condition(s) or problem(s) studied | Prevention of stroke in patients with carotid atherosclerosis treated with an innovative stent type |
| Intervention | In patients treated with micronet-covered stents for primary or secondary stroke prevention of carotid-related stroke, Optical Coherence Tomography (OCT) observation of stent coverage will be carried out at the point of another endovascular treatment performed at 1, 2 or 3 months after stent implantation. |
| Intervention type | Other |
| Primary outcome measure(s) |
Percentage of struts covered at 1, 2, or 3-months after stent implantation measured using Optical Coherence Tomography (OCT) |
| Key secondary outcome measure(s) |
Percentage of struts malapposed at 1, 2, or 3-months after stent implantation measured using Optical Coherence Tomography (OCT) |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Consecutive patients implanted with the micronet-covered stent (CGuard) in the carotid artery, who have indication to another (staged) endovascular intervention performed at 1, 2, or 3 months after the index carotd artery treatment. |
| Key exclusion criteria | 1. Lack of indication to staged endovascular treatment following idex carotid artery stenting with the Micronet-covered stent 2. Lack of consent |
| Date of first enrolment | 02/12/2024 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Poland
Study participating centre
80 Pradnicka St.
Krakow
31-202
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the curent study will be available upon reasonable request from the Principal Investigator (pmusialek@szpitaljp2.krakow.pl) |
Editorial Notes
16/12/2025: Trial's existence confirmed by Bioethical Committee of the Jagiellonian University.
