Physiology and Imaging Pre- and Post Stenting 2

Completed

• Conditions: arteriosclerosis; atherosclerosis; 10011082

• Registration Number: NL-OMON45423
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

In this study, patients from 18 years are eligible for inclusion if they are scheduled for PCI. De-novo lesions in a 3,0-3,5 mm artery up to 25mm are suitable to be treated.
All patients have to be able to give written informed consent.

Exclusion Criteria

- patients < 18 years
- Cardiogenic shock
- severe calcification or chronic occluded artery.
- bifurcation lesions
- previous bypass surgery
- pregnancy
- inability to give informed consent
- contra-indication for adenosine infusion such as allergy.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives:<br /><br>- Percentage of cases in which changes are made in selecting stent size and<br /><br>length after the initial OCT run compared to an angiographic based strategy.<br /><br>- Percentage of cases in which changes are made in post-stenting strategy after<br /><br>the final OCT run compared to an angiographic based strategy.<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>- Fractional flow reserve (FFR) measured before and after placement of the<br /><br>Magnesium biodegradable stent, to determine to what extend FFR is influenced by<br /><br>the presence of the stent in the vessel segment.<br /><br>- the occurence of cardiac events after 6 and 12 months follow up.</p><br>