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Physiology and Imaging Pre- and Post Stenting

Physiology and Imaging Pre- and Post Stenting - PIPPS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38867
Enrollment
40
Registered
2013-06-14
Start date
2013-08-06
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

atherosclerosis coronary artery disease

Interventions

None listed

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients 18 years or older - Signed informed consent - Stable angina or medically stabilized unstable angina, scheduled for PCI of 1- or 2-vessel disease - Vessel reference diameter of at least 2.5mm

Exclusion criteria

Exclusion criteria: - Severely tortuous and/or heavily calcified coronary arteries - Chronically occluded coronary arteries - Participation in other study - Pregnancy

Design outcomes

Primary

MeasureTime frame
Endpoints Primary endpoint Percentage of lesions with treatment change (post-dilatation, extra stent, 2B3A etc.) based on OCT/FFR post-PCI versus based on angiography. Statistical analysis - Primary endpoint: Estimated % of lesions treated additionally after stenting based on angiography:

Secondary

MeasureTime frame
Secondary endpoints Percentage of lesions with change in stent length and/or diameter pre-PCI, based on OCT/FFR pre-PCI versus based on angiography.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)