PAclitaxel-eluting balloon in Primary PCI in Amsterdam: 1-year angiographic evaluation of target lesion patency.
Withdrawn
- Conditions
- coronary artery disease100110821000759310003216
- Registration Number
- NL-OMON35497
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 75
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
- 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).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary angiographic endpoint to be evaluated is the late in-segment<br /><br>luminal loss as determined by laboratory measurement of the difference between<br /><br>the minimal lumen diameter (MLD) at follow-up catheterization and post-initial<br /><br>procedure. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include binary restenosis defined as >=50% diameter stenosis<br /><br>at follow-up, located within the target segment, respectively, and other<br /><br>angiographic results e.g. late occlusion.</p><br>