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PAclitaxel-eluting balloon in Primary PCI in Amsterdam: 1-year angiographic evaluation of target lesion patency.

PAclitaxel-eluting balloon in Primary PCI in Amsterdam: 1-year angiographic evaluation of target lesion patency. - PAPPA-patency

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35497
Enrollment
75
Registered
2011-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

coronary artery disease

Interventions

None listed

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients who are included in PAPPA-pilot (acute myocardial infarction presented for primary PCI within 12h after onset symptoms and treated with a paclitaxel-eluting ballon and additionally stentplacement if indicated) - patients understand the risk of coronary angiography and give written informed consent.

Exclusion criteria

Exclusion criteria: - revascularization of target lesion by PCI or coronary artery bypass grafting. - participation in another clinical study, interfering with this protocol. - renal impairment at risk for contrast nephropathy, defined as creatinin > 130 mmol/L (or >1.47 mg/dl) - the inability to provide written informed consent. - initial angiography not suitable for quantitative coronary angiography (QCA).

Design outcomes

Primary

MeasureTime frame
The primary angiographic endpoint to be evaluated is the late in-segment luminal loss as determined by laboratory measurement of the difference between the minimal lumen diameter (MLD) at follow-up catheterization and post-initial procedure.

Secondary

MeasureTime frame
Secondary endpoints include binary restenosis defined as >=50% diameter stenosis at follow-up, located within the target segment, respectively, and other angiographic results e.g. late occlusion.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)