Plain English Summary
Background and study aims
A bioresorbable scaffold (BRS) can hypothetically decrease the risk of an adverse cardiac event in the long-term perspective. The BRS is a device which is inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, manufactured from a material that may dissolve or be absorbed in the body. The of the study is to assess the long-term outcomes of using a BRS for the urgent treatment of coronary artery block.
Who can participate?
Patients undergoing surgery for STEMI type heart attack.
What does the study involve?
Patients undergoing urgent surgery for a STEMI type heart attack will be treated using the BRS and followed up over 5-years during their regular appointments.
What are the possible benefits and risks of participating?
An improved long-term outcome with normal vessel anatomy (no vessel metallic cage as the device is resorbed over time).
Higher risk of scaffold late thrombosis.
Where is the study run from?
1. University Hospital Kralovske Vinohrady third medical faculty, Charles University, Czechia
2. Military hospital Prague, Czechia
When is the study starting and how long is it expected to run for?
December 2012 to December 2020
Who is funding the study?
Univerzita Karlova v Praze (Charles University, Prague), Czechia
Who is the main contact?
Dr Petr Tousek,
Bioresorbable scaffold implantation in STEMI patients
Good longterm clinical outcome after bioresorbable scaffold (BRS) implantation, complete scaffold resorbtion at 5 year with stable lumen patency
1. Approved 09/01/2013, Local and multicenter ethical committee of the University Hospital Kralovske Vinohrady (Srobatrova 50, Prague 10, email@example.com, +420267162272), ref: EK-VP/02/2013
2. Amendment approved 03/10/2018, ref: EK-VP/02/4/2013
Prospective two-centre open-label registry study
Primary study design
Secondary study design
Patient information sheet
No participant information sheet available
Acute myocardial infarction with ST segment elevation
Use of bioresorbable scaffold (AbsorbTM BRS) during primary coronary intervention.
Patients enrolled in this study were treated during primary percutaneous coronary intervention (PCI) with the bioresorbable scaffold implantation (in some of the patients, optical coherence tomography (OCT) was performed just after BRS was implanted - if clinically possible).
Patients are followed by clinical and phone controls during 5 years.
First 25 eligible patients that agreed with the contol invasive imaging underwent 5 year coronary angiography and OCT.
Primary outcome measure
At 5 years:
1. Death using patient records
2. MI using patient records
3. Target vessel revascularization as recorded in records by a specialist
Secondary outcome measures
Vessel invasive assessment using QCA and optical coherence tomography at baseline and 5 years.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. STEMI patients
2. Sign informed consent
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Severe calcification
2. Do not meet specified vessel size
3. Length of the lesion more than 28mm
4. Indication for anticoagulation, cardiogenic shock
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Hospital Kralovske Vinohrady third medical faculty, Charles university
Trial participating centre
Military hospital Prague
U Vojenské nemocnice 1200
Univerzita Karlova v Praze
Charles University, Charles University in Prague, Univerzita Karlova, Karls-Universität zu Prag, UK
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Results and Publications
Publication and dissemination plan
Pilot study published in 2014, 2-year interim analysis published in 2016, imaging analysis planned to published in 2019, final results in 2020.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical restrictions on data sharing.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)