Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional Procedures

* Detailed Description for ClinicalTrials.gov Registration

* BACKGROUND

* Current State of Blood Pressure Monitoring in Interventional Procedures

Real-time, accurate hemodynamic monitoring is crucial during various interventional procedures. Currently, the clinical "gold standard" for continuous invasive arterial blood pressure monitoring is achieved through peripheral arterial catheterization (typically radial artery) connected to a pressure transducer, known as Radial Artery Catheterization (RAC). Although RAC provides beat-to-beat blood pressure data, it has several inherent limitations.

First, RAC insertion is an additional invasive procedure requiring extra time and technical skill, potentially delaying the start of the primary procedure. Studies have shown that RAC insertion requires an average of 10.7 minutes of additional time, with delays exceeding 80 minutes possible in complex cases. Second, the catheterization process may cause patient discomfort; research indicates that approximately 31.6% of patients experience pain after RAC insertion, with about 30% finding the pain bothersome. Additionally, RAC is associated with various potential complications, including radial artery occlusion (incidence approximately 5.5%), hand ischemia, infection, and thrombosis.

As an alternative, non-invasive blood pressure (NIBP) monitoring is widely used due to its convenience and safety. However, NIBP provides only intermittent readings and may fail to capture critical blood pressure fluctuations in rapidly changing hemodynamic scenarios. This is particularly important in neurointerventional procedures, where real-time blood pressure monitoring is essential for preventing and managing complications such as vasospasm and thrombosis.

\### Pressure Sensing Sheath Technology

Given the limitations of traditional monitoring methods, pressure sensing sheath technology has emerged as an innovative blood pressure monitoring approach. This technology integrates a miniature pressure sensor within the vascular access sheath, enabling continuous invasive blood pressure monitoring while establishing vascular access. Theoretically, this approach can simultaneously address the time consumption, patient discomfort, and monitoring discontinuity associated with traditional methods.

Internationally, pressure sensing sheath technology, represented by EndoPhys Corporation, has received U.S. FDA 510(k) clearance and entered clinical use. Purdy et al. first published accuracy validation research on pressure sensing sheath technology in 2017. Froehler et al. completed the first prospective controlled trial (Clinical Trial Registration Number: NCT03239847) in 2018, initially confirming the clinical value of this technology in neurointerventional procedures. However, existing studies are primarily single-center, small-sample investigations focused mainly on European and American populations, with a lack of randomized controlled trial evidence.

\### Study Rationale and Innovation

\#### Filling Evidence Gaps

Currently, there is a lack of high-quality prospective randomized controlled trial evidence to systematically verify whether pressure sensing sheath monitoring is non-inferior to the gold standard RAC in accuracy, and to comprehensively compare safety, procedural efficiency, and patient-physician satisfaction. Existing international studies have relatively small sample sizes (20-40 cases), and their external validity and generalizability require further verification.

* Establishing Standards for Chinese Population

Vascular anatomical structures and hemodynamic characteristics show certain racial differences. Vascular diameter, elasticity, and blood pressure variability patterns in the Chinese population may differ from those in European and American populations. This study will be the first to systematically evaluate the accuracy and safety of pressure sensing sheath technology in a Chinese population, providing scientific evidence for establishing application standards and operational specifications suitable for Chinese clinical practice.

* STUDY OBJECTIVES

* Primary Objective To assess the non-inferiority of the pressure sensing sheath blood pressure monitoring system compared to traditional radial arterial line invasive blood pressure monitoring combined with standard blood pressure cuff monitoring in terms of blood pressure reading accuracy during interventional procedures. * Secondary Objectives - To compare the safety of two monitoring methods

\- To evaluate procedural efficiency and operational convenience

\- To analyze patient comfort * STUDY HYPOTHESIS

* Primary Hypothesis The pressure sensing sheath monitoring system is non-inferior to traditional radial arterial line invasive blood pressure monitoring in measuring mean arterial pressure accuracy during interventional procedures, with the 95% limits of agreement between the two methods within the clinically acceptable range (±10 mmHg). * Secondary Hypothesis Pressure sensing sheath monitoring is superior to or equivalent to traditional radial arterial line monitoring in terms of safety, procedural efficiency, and patient comfort. * STUDY DESIGN

This is a prospective, single-center, self-controlled randomized, non-inferiority clinical study.

The study will enroll patients undergoing elective transradial interventional procedures requiring continuous invasive blood pressure monitoring (meeting inclusion criteria without exclusion criteria). Using a self-controlled randomized design, each patient will simultaneously receive both pressure sensing sheath blood pressure monitoring (experimental group) and traditional radial arterial line invasive blood pressure monitoring combined with standard blood pressure cuff monitoring (control group). The primary study endpoint is at 7 days. By synchronously comparing the performance of both monitoring methods in the same patient, individual differences are eliminated, demonstrating that pressure sensing sheath monitoring is non-inferior to traditional radial arterial line invasive blood pressure monitoring systems, thereby providing a superior monitoring option for clinical practice.

\### Randomization Scheme

Laterality Randomization: A random sequence will be generated to randomly determine whether the pressure sensing sheath monitoring system is inserted into the left or right radial artery, with the control group monitoring system inserted into the contralateral radial artery.

Monitoring Time Point Randomization: Block randomization design will be used to randomly determine specific blood pressure measurement time points within preset monitoring time windows, ensuring time synchronization and randomness of monitoring for both groups.

Experimental Group: Pressure sensing sheath monitoring system (inserted via radial artery)

Control Group: Traditional radial arterial line invasive blood pressure monitoring system combined with standard blood pressure cuff monitoring

\---

\## STUDY POPULATION

* Data Source This study's data will be collected from Shanghai Fourth People's Hospital Affiliated to Tongji University using a prospective, single-center data collection approach. Study subjects will be patients aged ≥18 years scheduled to undergo elective transradial interventional procedures requiring continuous invasive blood pressure monitoring according to standard medical operational procedures. Data collection period will be from September 15, 2025, to May 31, 2027, with an anticipated enrollment of 50 patients meeting inclusion criteria. * Diagnostic Criteria

This study primarily targets patients requiring transradial interventional procedures with continuous invasive blood pressure monitoring. Disease diagnostic criteria include:

Indications for Interventional Procedures: According to relevant clinical guidelines and expert consensus, diseases requiring transradial interventional treatment primarily include acute cerebral infarction, aneurysms, arteriovenous malformations, carotid artery stenosis, and other cerebrovascular diseases. Specific diagnostic criteria reference the latest cerebrovascular disease diagnosis and treatment guidelines, including comprehensive evaluation of clinical symptoms, imaging examinations (CT/CTA/MRI/MRA/DSA), and laboratory test results.

Indications for Continuous Invasive Blood Pressure Monitoring: According to clinical needs and standard medical operational procedures, patients requiring radial arterial catheterization for invasive blood pressure monitoring include: interventional procedure patients requiring real-time, accurate blood pressure monitoring to guide treatment; patients with potentially unstable hemodynamics requiring close monitoring; patients requiring precise blood pressure control during procedures to prevent complications.

* Inclusion Criteria

* Age ≥18 years * Patients scheduled for elective transradial interventional procedures requiring continuous invasive blood pressure monitoring * Patients who must undergo radial arterial catheterization for invasive blood pressure monitoring according to clinical needs and standard medical operational procedures * Patients who can understand the study purpose, voluntarily participate and sign informed consent, and are willing to undergo relevant examinations and clinical follow-up * Exclusion Criteria

* Patients with contraindications to radial artery access * Patients with hemodynamic instability * Patients requiring postoperative continuous invasive blood pressure monitoring * Patients unable to provide informed consent * Patients with known severe aortic or subclavian artery stenosis or occlusion * Patients with severe coagulation dysfunction (INR ≥2.0, platelet count \<75×10⁹/L) * BMI \>40 kg/m² * Severe heart failure (NYHA Class IV) or patients requiring emergency rescue with hemodynamic instability * Withdrawal Criteria

* Symptom deterioration or clinical complications preventing scheduled procedure * Subject wishes to pursue non-protocol treatment * Subject voluntarily withdraws from the study for any reason

* STUDY ENDPOINTS * Primary Endpoint

Mean Arterial Pressure (MAP) Agreement Analysis:

* Bland-Altman method to analyze agreement between pressure sensing sheath monitoring and radial artery monitoring * Calculate 95% limits of agreement * Evaluate mean and standard deviation of differences between the two methods * Non-inferiority criterion: 95% limits of agreement within ±10 mmHg * Synchronously evaluate agreement between pressure sensing sheath monitoring and standard blood pressure cuff monitoring as a reference comparison

* Secondary Endpoints

• Agreement of Systolic and Diastolic Blood Pressure [Time frame: Intraoperative (duration of procedure, approximately 1-4 hours)]
• Procedural Efficiency [Time frame: From patient entry to operating room until completion of procedure setup (approximately 10-30 minutes)]
• Incidence of Access Site Complications [Time frame: From procedure start through 7 days post-procedure]
• Patient-Reported Puncture Site Pain Score [Time frame: 24 hours and 7 days post-procedure]