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

Coronary Heart Disease Clinical Trial

— ROBUST  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00888758
• Other study ID #: 06042006
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 27, 2009
• Last updated: April 30, 2009
• Start date: May 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2009
• Source: Masaryk University
• Contact: Pavel Cervinka, MD,PhD
• Phone: +420477117886
• Email: pavel.cervinka[@]mnul.cz
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Device:
• biolimus A9
200 patients with STEMI will be treated using Biomatrix stent.
• everolimus
200 patients with STEMI will be treated with PROMUS DES.

Locations

Country	Name	City	State
Czech Republic	Department of Cardiology, Masaryk hospital and University of JEP	Ústí nad Labem

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk University

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	number of uncovered stent struts		2 years	No
Secondary	number of malaposed stents struts		2 years	No
Secondary	in-stent neointimal volume		2 years	No
Secondary	in-segment assessment of vessel wall response to DES		2 years	No