Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction

Randomized Comparison of Biolimus-Eluting and Everolimus-Eluting Stents With Optical Coherence Tomography Guided Stent Implantation in ST Elevation Myocardial Infarction.A 9-Month Angiographic and Optical Coherence Tomography Follow-up.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00888758

Acronym

ROBUST

Enrollment

400

Registered

2009-04-28

Start date

2009-05-31

Completion date

2011-05-31

Last updated

2009-05-01

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

Conditions

Coronary Heart Disease, Percutaneous Coronary Intervention

Keywords

Stents

Brief summary

The primary objective of this study is: * comparison of a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9 month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both groups. The secondary outcomes are a comparison of (using OCT): * number of uncovered stent struts * number of malapposed stents struts * in-stent neointimal volume * in-segment assessment of vessel wall response to DES

Detailed description

The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group.

Interventions

DEVICEbiolimus A9

200 patients with STEMI will be treated using Biomatrix stent.

DEVICEeverolimus

200 patients with STEMI will be treated with PROMUS DES.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Acute STEMI within 12 hours from symptoms onset 2. Native coronary disease with a lesion suitable for stenting 3. Vessel size in between 2.5-3.75mm 4. Patient is willing to provide written informed consent 5. Male or female patients between 18-85 years of age

Exclusion criteria

1. Significant left main disease 2. Killip class IV 3. Known allergy to aspirin and or clopidogrel/ticlopidine 4. Recent bleeding (\<1month) 5. Patient in anticoagulant therapy 6. No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel /\>3.75mm in diameter/) 7. Pregnancy 8. Severe liver or renal disease (Cr\>2.0) 9. Life expectancy \< 1 year

Design outcomes

Primary

Measure	Time frame
to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up	2 years

Secondary

Measure	Time frame
number of uncovered stent struts	2 years
number of malaposed stents struts	2 years
in-stent neointimal volume	2 years
in-segment assessment of vessel wall response to DES	2 years

Countries

Czechia

Contacts

Primary ContactPavel Cervinka, MD,PhD

pavel.cervinka@mnul.cz+420477117886

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026