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

NCT ID: NCT00888758

Last Updated: 2009-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-05-31

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.

Conditions

Coronary Heart Disease; Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

biolimus A9

Intervention Type: DEVICE

200 patients with STEMI will be treated using Biomatrix stent.

2

Group Type: ACTIVE_COMPARATOR

everolimus

Intervention Type: DEVICE

200 patients with STEMI will be treated with PROMUS DES.

Interventions

biolimus A9

200 patients with STEMI will be treated using Biomatrix stent.

Intervention Type: DEVICE

everolimus

200 patients with STEMI will be treated with PROMUS DES.

Intervention Type: DEVICE

Other Intervention Names

biolimus A9 eluting stent; everolimus eluting stent

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masaryk University

OTHER

Sponsor Role: lead

Responsible Party

Masaryk hospital and University of JEP Ústí nad Labem

Principal Investigators

Pavel Cervinka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Krajska zdravotni a.s., Masarzk hospital Usti nad Labem

Locations

Department of Cardiology, Masaryk hospital and University of JEP

Ústí nad Labem, , Czechia

Countries

Czechia

Central Contacts

Pavel Cervinka, MD,PhD

Role: CONTACT

pavel.cervinka@mnul.cz

+420477117886

Facility Contacts

Pavel Cervinka, MD,PhD

Role: primary

pavel.cervinka@mnul.cz

+420477117886

Other Identifiers

06042006

Identifier Type: -

Identifier Source: org_study_id