PMCF Study of Precise Pro Rx for Carotid Artery Disease

NCT07204678 | Completed FDA Device

• 1 other identifier: P21-7903
• Study Type: observational
• Target: 199
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Carotid Artery Stenosis

Keywords

Carotid artery stenosis; PRECISE PRO Rx Nitinol Stent System

Outcome Measures

Primary Outcomes (7)

• 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

  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

  At 12 months

• Safety Endpoint - All-Cause Mortality

  All site-reported events of all-cause mortality

  Through 5 years

• Safety Endpoint - Myocardial Infarction

  All site-reported events of myocardial infarction

  Through 5 years.

• Safety Endpoint - Major Stroke

  A major stroke is defined as a cerebrovascular accident

  Through 5 years

• Safety Endpoint - Minor Stroke

  A minor stroke is defined as a transient ischemic attack

  Through 5 years

• Safety Endpoint - Thrombosis

  All site-reported events of thrombosis

  Through 5 years

Other Outcomes (3)

• Stent Patency

  Through 5 years

• All adverse events

  Through 5 years

• In-Stent Restenosis (ISR)

  Through 5 years

Study Arms (1)

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

Device: PRECISE PRO Rx Nitinol Stent System

Interventions

PRECISE PRO Rx Nitinol Stent System DEVICE

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).

Subjects treated with the PRECISE PRO Rx Nitinol Stent System

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

Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis.

You may qualify if:

• 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

You may not qualify if:

• Women who were pregnant or lactating at the time of the procedure
• Pediatric subjects (\<18 years of age) at the time of the procedure

Sponsors & Collaborators

• Cordis US Corp.: lead
• Rede Optimus Hospitalar SA: collaborator

Study Sites (4)

University Hospital Tulln

Tulln, 3430, Austria

Location

Hospital Pellegrin Bordeaux

Bordeaux, France

Location

Pineta Grande Hospital

Castel Volturno, Italy

Location

I.R.C.C.S. San Donato Polyclinic

Milan, Italy

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nusrath Sultana

  Cordis US Corp.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 30, 2025
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (1); IT (2); AU (1)