Skip to content

Drug Eluting Balloon in Acute Myocardial Infarction

Drug Eluting Balloon in Acute Myocardial Infarction - DEB-AMI

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35144
Enrollment
200
Registered
2008-11-18
Start date
2009-02-23
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 disease myocardial infarction

Interventions

PCI is currently the standard treatment for patients with AMI. Several types of balloons and stents are being used. In the current study we will investigate different approaches of DEB and DES and B

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age: 18-80 year - STEMI within 12 hours of onset of complaints - Candidate for primary PCI with stent-implantation - Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow * 1.

Exclusion criteria

Exclusion criteria: - Unable to give written informed consent - Previous PCI or CABG of infarct related vessel - Left main stenosis * 50%. - Severe triple vessel disease with stenosis * 50% in 3 epicardial coronary arteries. - Target vessel reference diameter 4.0 mm - Target lesion length

Design outcomes

Primary

MeasureTime frame
Late loss of lumen diameter between index procedure and 6 month angiographic follow-up.

Secondary

MeasureTime frame
1) Binary restenosis ( > 50 % ) at 6 month follow*up 2) Stent malapposition at 6 month follow*up 3) Endothelial dysfunction at 6 month follow*up 4) Clinical outcome at 1 and 5 year follow*up

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)