Carotid Artery StenosisREAL-PRECISENCT07204678
PMCF Study of Precise Pro Rx for Carotid Artery Disease
An observational study of Carotid Artery Stenosis, run by Cordis US Corp. at 4 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate long-term clinical safety and performance of the PRECISE PRO RX Nitinol Stent System to treat stenotic lesions of the carotid arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- PRECISE PRO Rx Nitinol Stent System
- Type of treatment
- Medical device
- How many people
- 199 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 30 Oct 2025to 27 Feb 2026
- 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: Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis.
Who may be able to join
- Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis
- If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data
Who cannot join
- Women who were pregnant or lactating at the time of the procedure
- Pediatric subjects (<18 years of age) at the time of the procedure
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Italy2 sites
Pineta Grande Hospital
Castel Volturno
I.R.C.C.S. San Donato Polyclinic
Milan
About this study
Official title: Post Market Clinical Follow-up Study of the Precise Pro Rx Nitinol Stent System in the Treatment of Carotid Artery Disease (REAL-PRECISE)
The purpose of this study is to evaluate long-term clinical safety and performance of the PRECISE PRO RX Nitinol Stent System to treat stenotic lesions of the carotid arteries.
Read the detailed description
The REAL-PRECISE study is a multi-center, non-randomized, observational analysis of retrospective data collected on subjects treated with PRECISE PRO Rx Nitinol Stent System. The purpose of this study is to evaluate the long-term (5-year) safety and performance of PRECISE PRO Rx Nitinol Stent System in subjects with stenotic lesions of the carotid arteries. The study is conducted in up to 15 European study sites in approximately 3 countries with high volume use of PRECISE PRO Rx. The enrollment and data collection takes approximately 4-6 months.
- Conditions
- Carotid Artery Stenosis
- Being tested
- PRECISE PRO Rx Nitinol Stent System
- Keywords
- Carotid artery stenosis, PRECISE PRO Rx Nitinol Stent System
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECISE PRO Rx Nitinol Stent SystemDevice
The Cordis PRECISE PRO Rx Nitinol Stent System is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the carotid artery(ies). The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The Cordis PRECISE PRO Rx Nitinol Stent System is indicated for use in patients with stenotic lesions of the carotid artery(ies).
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with the PRECISE PRO Rx Nitinol Stent System | Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis Receives: Device: PRECISE PRO Rx Nitinol Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Endpoint - Technical Success
Achievement of a final residual stenosis of <30% at the target lesion using any percutaneous method at the conclusion of the index procedure
Measured: At the conclusion of the index procedure
Performance Endpoint - Target Lesion Revascularization (TLR) at 12 months
A repeat revascularization procedure performed at the original treatment site due to restenosis of ≥50% at the target lesion (as confirmed by quantitative angiography) in the presence of symptoms or ≥80% in the absence of symptoms
Measured: At 12 months
Safety Endpoint - All-Cause Mortality
All site-reported events of all-cause mortality
Measured: Through 5 years
Safety Endpoint - Myocardial Infarction
All site-reported events of myocardial infarction
Measured: Through 5 years.
Safety Endpoint - Major Stroke
A major stroke is defined as a cerebrovascular accident
Measured: Through 5 years
Safety Endpoint - Minor Stroke
A minor stroke is defined as a transient ischemic attack
Measured: Through 5 years
Safety Endpoint - Thrombosis
All site-reported events of thrombosis
Measured: Through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start30 Oct 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies 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
- Retrospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rede Optimus Hospitalar SA
- Responsible party
- Sponsor
- Investigators
- Nusrath Sultana, Study director, Cordis US Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204678
- Sponsor's protocol ID
- P21-7903
- Acronym
- REAL-PRECISE
- Status last verified
- Mar 2026
- First submitted
- 24 Sep 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up Study of the Precise Pro Rx Nitinol Stent System in the Treatment of Carotid Artery Disease (REAL-PRECISE)
- ClinicalTrials.gov ID
- NCT07204678
- Acronym / sponsor ID
- REAL-PRECISE / P21-7903
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid artery stenosis, PRECISE PRO Rx Nitinol Stent System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- Rede Optimus Hospitalar SA
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 2 Oct 2025 (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.
The purpose of this study is to evaluate long-term clinical safety and performance of the PRECISE PRO RX Nitinol Stent System to treat stenotic lesions of the carotid arteries.
Detailed description
The REAL-PRECISE study is a multi-center, non-randomized, observational analysis of retrospective data collected on subjects treated with PRECISE PRO Rx Nitinol Stent System. The purpose of this study is to evaluate the long-term (5-year) safety and performance of PRECISE PRO Rx Nitinol Stent System in subjects with stenotic lesions of the carotid arteries. The study is conducted in up to 15 European study sites in approximately 3 countries with high volume use of PRECISE PRO Rx. The enrollment and data collection takes approximately 4-6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with the PRECISE PRO Rx Nitinol Stent System | – | Device: PRECISE PRO Rx Nitinol Stent SystemSubjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis.
Key inclusion criteria (2 listed)
- Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis
- If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data
Key exclusion criteria (2 listed)
- Women who were pregnant or lactating at the time of the procedure
- Pediatric subjects (<18 years of age) at the time of the procedure
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 |
|---|---|---|
| PRECISE PRO Rx Nitinol Stent SystemThe Cordis PRECISE PRO Rx Nitinol Stent System is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the carotid artery(ies). The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The Cordis PRECISE PRO Rx Nitinol Stent System is indicated for use in patients with stenotic lesions of the carotid artery(ies). | Device | Subjects treated with the PRECISE PRO Rx Nitinol Stent System |
Primary outcome
Performance Endpoint - Technical Success
Time frame: At the conclusion of the index procedure
Achievement of a final residual stenosis of <30% at the target lesion using any percutaneous method at the conclusion of the index procedure
Performance Endpoint - Target Lesion Revascularization (TLR) at 12 months
Time frame: At 12 months
A repeat revascularization procedure performed at the original treatment site due to restenosis of ≥50% at the target lesion (as confirmed by quantitative angiography) in the presence of symptoms or ≥80% in the absence of symptoms
Safety Endpoint - All-Cause Mortality
Time frame: Through 5 years
All site-reported events of all-cause mortality
Safety Endpoint - Myocardial Infarction
Time frame: Through 5 years.
All site-reported events of myocardial infarction
Safety Endpoint - Major Stroke
Time frame: Through 5 years
A major stroke is defined as a cerebrovascular accident
Safety Endpoint - Minor Stroke
Time frame: Through 5 years
A minor stroke is defined as a transient ischemic attack
Safety Endpoint - Thrombosis
Time frame: Through 5 years
All site-reported events of thrombosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Nusrath Sultana study director
Cordis US Corp.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis, run by Cordis US Corp. at 4 sites in 3 countries.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Austria, France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Endpoint - Technical Success (time frame: At the conclusion of the index procedure). The study lists 7 primary outcomes in all. 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 13 Mar 2026.