Myocardial Infarction Clinical Trial
— ISAR-Absorb MIOfficial title:
Intracoronary Scaffold Assessment a Randomised Evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
Verified date | July 2018 |
Source | Deutsches Herzzentrum Muenchen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI.
Status | Active, not recruiting |
Enrollment | 262 |
Est. completion date | March 2019 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients 18 years or older with acute ST-elevation myocardial infarction or non ST-elevation myocardial infarction with angiographically confirmed thrombus 2. Planned stent implantation in de novo lesions in native vessels or coronary bypass grafts with reference vessel diameter =2.5 mm and =3.9 mm 3. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study 4. In women with childbearing potential a negative pregnancy test is mandatory Exclusion Criteria: 1. Target lesion located in the left main trunk 2. Severely calcified lesions 3. Bifurcation lesions with side branch diameter > 2mm 4. In-stent restenosis 5. Contraindications to antiplatelet therapy, cobalt chrome, everolimus, polylactic acid 6. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance 7. Pregnancy (present, suspected or planned) or positive pregnancy test. 8. Previous enrolment in this trial 9. Patient's inability to fully cooperate with the study protocol |
Country | Name | City | State |
---|---|---|---|
Germany | Deutsches Herzzentrum Munich | Munich | Bavaria |
Germany | Klinikum Rechts der Isar | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Deutsches Herzzentrum Muenchen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage Diameter Stenosis | Percentage diameter stenosis at coronary angiography at 6-8 months follow-up | 6-8 months | |
Secondary | Device-oriented composite endpoint | Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR) | 12 months | |
Secondary | Patient-oriented composite endpoint | The composite of death/any MI/all revascularization | 12 months | |
Secondary | Composite of death or MI | The composite of cardiovascular death or MI | 12 months | |
Secondary | Stent thrombosis | The incidence of scaffold or stent thrombosis | 12 months |
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