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Physiology and Imaging Pre- and Post Stenting 2

Physiology and Imaging Pre- and Post Stenting 2 - PIPPS 2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45423
Enrollment
40
Registered
2017-09-22
Start date
2018-05-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arteriosclerosis atherosclerosis

Interventions

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: - patients

Design outcomes

Primary

MeasureTime frame
Primary objectives: - Percentage of cases in which changes are made in selecting stent size and length after the initial OCT run compared to an angiographic based strategy. - Percentage of cases in which changes are made in post-stenting strategy after the final OCT run compared to an angiographic based strategy.

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)