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Completed

NCT Number: NCT07204678

PMCF Study of Precise Pro Rx for Carotid Artery Disease

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tulln, Tulln, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

NOTE: This is a RETROSPECTIVE study designed to collect outcomes on subjects who were already treated with the study device.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. 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

  2. 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

  3. Safety Endpoint - All-Cause Mortality

    Time frame: Through 5 years

    All site-reported events of all-cause mortality

  4. Safety Endpoint - Myocardial Infarction

    Time frame: Through 5 years.

    All site-reported events of myocardial infarction

  5. Safety Endpoint - Major Stroke

    Time frame: Through 5 years

    A major stroke is defined as a cerebrovascular accident

  6. Safety Endpoint - Minor Stroke

    Time frame: Through 5 years

    A minor stroke is defined as a transient ischemic attack

  7. Safety Endpoint - Thrombosis

    Time frame: Through 5 years

    All site-reported events of thrombosis

Other outcomes

  1. Stent Patency

    Time frame: Through 5 years

    The stent patency is defined as 30% stenosis immediately post-stent placement and < 50% stenosis long-term

  2. All adverse events

    Time frame: Through 5 years

    All adverse events reported by sites

  3. In-Stent Restenosis (ISR)

    Time frame: Through 5 years

    All site-reported events of In-Stent Restenosis (ISR) evaluated through any imaging assessment performed

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Collaborators

  • Rede Optimus Hospitalar SA

Registry information

Official study title

Post Market Clinical Follow-up Study of the Precise Pro Rx Nitinol Stent System in the Treatment of Carotid Artery Disease (REAL-PRECISE)

Acronym: REAL-PRECISE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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