The effectiveness of new bioresorbable coronary stents in the treatment of patients with acute coronary syndromes
| ISRCTN | ISRCTN89434356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89434356 |
| Secondary identifying numbers | EK-VP-29-0-2017 |
- Submission date
- 09/05/2021
- Registration date
- 12/05/2021
- Last edited
- 13/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Acute coronary syndromes are a range of conditions associated with suddenly reduced blood flow to the heart. They can be treated with percutaneous coronary intervention (PCI), where a tube-shaped device called a coronary stent is placed in the coronary arteries that supply blood to the heart to keep them open. There is little evidence about the effectiveness and safety of magnesium-based bioresorbable (naturally-dissolving) coronary stents in patients with acute coronary syndromes. The aim of this study is to compare the bioresorbable Magmaris stent with the drug-eluting (drug-releasing) Xience stent in patients with acute coronary syndromes undergoing PCI.
Who can participate?
Patients with acute coronary syndromes
What does the study involve?
Participants are randomly allocated to undergo PCI with either a bioresorbable stent or a drug-eluting stent. Participants in both groups are followed for 12 months with heart scans at 12 months.
What are the possible benefits and risks of participating?
The study will provide information about the effects of the coronary intervention at 12 months. There is a small risk (mainly minimal bleeding) with respect to repeat invasive imaging at 12 months.
Where is the study run from?
University Hospital Kralovske Vinohrady (Czech Republic)
When is the study starting and how long is it expected to run for?
March 2017 to January 2021
Who is funding the study?
1. University Hospital Kralovske Vinohrady (Czech Republic)
2. Charles University in Prague (Czech Republic)
Who is the main contact?
Petr Tousek
petr.tousek@fnkv.cz
Contact information
Public
Srobarova 50
Praha 10
10034
Czech Republic
 ORCID ID |
0000-0002-2598-3635 |
|---|---|
| Phone | +420 (0)267162621 |
| petr.tousek@fnkv.cz |
Study information
| Study design | Two-centre investigator-initiated academic randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact detail to request a participant information sheet |
| Scientific title | Bioresorbable magnesium-based sirolimus-eluting stent versus permanent metallic everolimus-eluting stent in patients with acute coronary syndromes |
| Study acronym | PRAGUE-22 |
| Study objectives | The bioresorbable magnesium-based sirolimus-eluting stent has similar 12-months efficacy compared to the everolimus-eluting metallic stent in patients with acute coronary syndromes. |
| Ethics approval(s) | Approved 28/06/2017, University Hospital Kralovske Vinohrady Ethics Committee (Srobarova 1150/50, 100 34 Prague, Czech Republic; +420 (0)267 16 2272; eticka.komise@fnkv.cz), ref: EK-VP-29-0-2017 |
| Health condition(s) or problem(s) studied | Acute coronary syndromes |
| Intervention | Participants are randomised using the envelope method into two arms. Both groups undergo percutaneous coronary intervention (PCI): one arm undergoes bioresorbable stent implantation (Magmaris stent) and the other group second-generation drug-eluting stent (XIENCE) implantation. Participants in both groups are followed for 12 months with control angiography and optical coherence tomography (OCT) imaging at 12 months. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Late lumen loss assessed by quantitative coronary angiography (QCA) and optical coherance tomography (OCT) at 12 months follow-up |
| Secondary outcome measures | 1. Device and procedural success (devices implanted by physician with optimal expansion, time) recorded at the time of the procedure 2. Clinical combined endpoints (death, stent thrombosis, target vessel myocardial infarction, clinically driven target lesion failure), measured at 12 months 3. Magmaris resorption assessed by OCT at 12 months 4. Healing state assessed by OCT at 12 months |
| Overall study start date | 01/03/2017 |
| Completion date | 31/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | Patients were included if they presented with: 1. ST-elevation myocardial infarction (STEMI) <24 hours since the onset of symptoms or 2. Non-ST-elevation myocardial infarction (non-STEMI) or 3. Unstable angina caused by thrombotic acute coronary stenosis and coronary artery with stenosis diameter suitable for implantation of both investigated types of stents (vessel diameter between 2.7 and 3.7 mm) |
| Key exclusion criteria | 1. Cardiogenic shock or pulmonary oedema 2. Expected survival less than 3 years due to severe comorbidities 3. Contraindication of 12 months dual antiplatelet treatment including an indication to treatment with peroral anticoagulants 4. Diffuse calcifications or extreme tortuosity of the target vessel 5. In-stent restenosis or stent thrombosis as the culprit lesion 6. Left main stenosis |
| Date of first enrolment | 01/07/2017 |
| Date of final enrolment | 20/01/2020 |
Locations
Countries of recruitment
- Czech Republic
Study participating centres
Prague
10034
Czech Republic
Kyjevská 44
Pardubice
53203
Czech Republic
Sponsor information
Hospital/treatment centre
Srobarova 1150/50
Prague
100 34
Czech Republic
| Phone | +420 (0)26716111 |
|---|---|
| kardsekr@fnkv.cz | |
| Website | https://www.fnkv.cz |
"ROR" |
https://ror.org/04sg4ka71 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Charles University, Charles University in Prague, Univerzita Karlova, Karls-Universität zu Prag, UK
- Location
- Czech Republic
No information available
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be presented in late-breaking clinical trials during EuroPCR 2021 |
| IPD sharing plan | Participant level data will be available upon request to principal investigator Petr Tousek (petr.tousek@fnkv.cz). Data are already available, will be available for 5 years, and are anonymized. Participant consent was not obtained for sharing other data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/09/2021 | 13/09/2021 | Yes | No |
Editorial Notes
13/09/2021: Publication reference added.
16/07/2021: Internal review.
12/05/2021: Trial's existence confirmed by the University Hospital Kralovske Vinohrady Ethics Committee.
