Long-term outcomes for heart attack patients treated with a naturally-dissolving blood vessel support
| ISRCTN | ISRCTN43696201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43696201 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Charles University, University Research programme UNCE 02 and PROGRES Q38 |
| Funder | Univerzita Karlova v Praze |
- Submission date
- 04/06/2019
- Registration date
- 07/06/2019
- Last edited
- 20/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
University Hospital Vinohrady
Srobarova 50
Prague
10034
Czech Republic
 ORCID ID |
0000-0002-2598-3635 |
|---|---|
| Phone | 0042 067162701 |
| petr.tousek@fnkv.cz |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective two-centre open-label registry study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Bioresorbable scaffold implantation in STEMI patients |
| Study acronym | PRAGUE-19 |
| Study objectives | Good longterm clinical outcome after bioresorbable scaffold (BRS) implantation, complete scaffold resorbtion at 5 year with stable lumen patency |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
At 5 years: |
| Key secondary outcome measure(s) |
Vessel invasive assessment using QCA and optical coherence tomography at baseline and 5 years. |
| Completion date | 15/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 130 |
| Total final enrolment | 117 |
| Key inclusion criteria | 1. STEMI patients 2. Sign informed consent |
| Key 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 |
| Date of first enrolment | 15/12/2012 |
| Date of final enrolment | 15/12/2015 |
Locations
Countries of recruitment
- Czech Republic
Study participating centres
Prague
10034
Czech Republic
Prague
16902
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/01/2020 | 03/02/2020 | Yes | No | |
| Other publications | interim analysis | 17/05/2016 | 05/06/2019 | Yes | No |
| Other publications | pilot study | 01/03/2014 | 05/06/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/01/2022: Internal review.
03/02/2020: Publication reference added.
07/06/2019: Trial’s existence confirmed by University Hospital Kralovske Vinohrady.
