Condition category
Circulatory System
Date applied
04/06/2019
Date assigned
07/06/2019
Last edited
07/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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,
petr.tousek@fnkv.cz

Trial website

Contact information

Type

Scientific

Primary contact

Dr Petr Tousek

ORCID ID

http://orcid.org/0000-0002-2598-3635

Contact details

University Hospital Vinohrady
Srobarova 50
Prague
10034
Czech Republic
0042 067162701
petr.tousek@fnkv.cz

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Bioresorbable scaffold implantation in STEMI patients

Acronym

PRAGUE-19

Study hypothesis

Good longterm clinical outcome after bioresorbable scaffold (BRS) implantation, complete scaffold resorbtion at 5 year with stable lumen patency

Ethics approval

1. Approved 09/01/2013, Local and multicenter ethical committee of the University Hospital Kralovske Vinohrady (Srobatrova 50, Prague 10, eticka.komise@fnkv.cz, +420267162272), ref: EK-VP/02/2013
2. Amendment approved 03/10/2018, ref: EK-VP/02/4/2013

Study design

Prospective two-centre open-label registry study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Acute myocardial infarction with ST segment elevation

Intervention

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.

Intervention type

Device

Phase

Phase IV

Drug names

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

01/12/2012

Overall trial end date

15/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. STEMI patients
2. Sign informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Total final enrolment

117

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

15/12/2012

Recruitment end date

15/12/2015

Locations

Countries of recruitment

Czech Republic

Trial participating centre

University Hospital Kralovske Vinohrady third medical faculty, Charles university
Srobarova 50
Prague
10034
Czech Republic

Trial participating centre

Military hospital Prague
U Vojenské nemocnice 1200
Prague
16902
Czech Republic

Sponsor information

Organisation

Charles University, University Research programme UNCE 02 and PROGRES Q38

Sponsor details

Ruska 87
Prague
10000
Czech Republic
267162701
petr.tousek@f3.cuni.cz

Sponsor type

University/education

Website

www.cuni.cz

Funders

Funder type

University/education

Funder name

Univerzita Karlova v Praze

Alternative name(s)

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)

Location

Czech Republic

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

31/12/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2014 pilot study in: https://www.ncbi.nlm.nih.gov/pubmed/24419808 (added 05/06/2019)
2016 interim analysis in: https://www.ncbi.nlm.nih.gov/pubmed/27173858 (added 05/06/2019)

Publication citations

Additional files

Editorial Notes

07/06/2019: Trial’s existence confirmed by University Hospital Kralovske Vinohrady.