Trials / Completed
CompletedNCT03782688
Precise Percutaneous Coronary Intervention Plan (P3) Study
Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 127 (actual)
- Sponsor
- Onze Lieve Vrouw Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.
Detailed description
Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying the presence of significant coronary stenosis by means of coronary angiography and invasive fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures: Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation drug-eluting stent.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | FFRCT planner | Non-invasive post-PCI fractional flow reserve prediction |
Timeline
- Start date
- 2019-02-01
- Primary completion
- 2020-12-18
- Completion
- 2021-12-18
- First posted
- 2018-12-20
- Last updated
- 2023-03-23
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03782688. Inclusion in this directory is not an endorsement.