Six-Month Clinical and Angiographic Follow up of Everolimus eluting bioresorbable vascular scaffold in patients presenting with ST-segment elevation myocardial infarction

Six-Month Clinical and Angiographic Follow up of Everolimus eluting bioresorbable vascular scaffold in patients presenting with ST-segment elevation myocardial infarction - BVS-STEMI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40314

Enrollment

Registered

2013-07-22

Start date

2013-08-13

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

stent couverage strut apposition

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patient is at least 18 years of age. 2. Patient has been treated, within the previous 6 month, with BVS for primary PCI . 3. For the pre-specified subgroup of 30 patients, an OCT study of the treated culprit lesion after BVS implantation should be available for analysis. 4. Treated target lesion must be a de-novo lesion located in a native vessel. 5. Signed Informed Consent. 6. The patient understands and accepts the meaning and the aims of the study

Exclusion criteria

Exclusion criteria: 1. Pregnancy. 2. Known intolerance to contrast material. 3. Known thrombocytopenia (PLT

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the evaluation of the healing process defined as scaffold apposition and coverage at 6-month follow-up by invasive coronary imaging with Optical Coherence Tomography.	—

Secondary

Measure	Time frame
The secondary OCT objective is the serial assessment of strut apposition from baseline to 6-month follow-up in a subgroup of patients where an OCT study has been performed at baseline, as clinically indicated.	—

Countries

Netherlands

Outcome results