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Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

NCT04451044 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3212

Last updated 2025-01-20

No results posted yet for this study

Summary

Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

Conditions

Interventions

DEVICE

Philips SyncVision system with Philips pressure wires

Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy

PROCEDURE

standard of care angiographically-guided PCI

Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy

Sponsors & Collaborators

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Principal Investigators

  • Allen Jeremias, MD MSC FACC FSCAI · Saint Francis Hospital

  • Gregg W Stone, MD · The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2026-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04451044 on ClinicalTrials.gov