Coronary Artery PerforationCRACKNCT04630314
Covered Stents in Treatment of Coronary Artery Perforation
An observational study of Coronary Artery Perforation, run by Medical University of Silesia at 6 sites in Poland.
Trial summary
Covered stents have been mainly used for treatment of potentially life-threatening coronary artery perforation and coronary artery aneurysm. Prior studies suggest that the use of covered stents improves event-free survival, enabling a life-threatening situation to be managed without emergency surgery and with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Perforation
- What is being tested?
- Percutaneus Coronary Intervention
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 6 sitesPoland
- Study dates
- 1 Jan 2009to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: All consecutive patients
Who may be able to join
- Iatrogenic, peri-PCI CAP treated with covered stent implantation
Who cannot join
- CAP caused due to other cause than PCI
- PCI of other vascular territories during the same procedure
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Poland6 sites
Department of Invasive Cardiology, Medical University of Białystok
Bialystok
First Department of Cardiology, Medical University of Gdansk
Gdansk
Wojciech Wańha
Katowice, 40-055
Second Department of Cardiology, Jagiellonian University Medical College
Krakow
Miedziowe Centrum Zdrowia S.A.
Lubin
Third Department of Cardiology, Medical University of Katowice
Zabrze
About this study
Official title: Procedural and 1-year Outcomes Following Large Vessel Coronary Artery Perforation Treated by Covered Stents Implantation: Multicentre CRACK Registry
Covered stents have been mainly used for treatment of potentially life-threatening coronary artery perforation and coronary artery aneurysm. Prior studies suggest that the use of covered stents improves event-free survival, enabling a life-threatening situation to be managed without emergency surgery and with significantly reduced rates of mortality, cardiac tamponade, and major adverse cardiac events. Although the devices are used for a long time, very limited study has described procedural-related outcomes with this specific technology. We therefore want to report procedural, in-hospital and long term outcomes among patients treated with the covered stents.
- Conditions
- Coronary Artery Perforation
- Being tested
- Percutaneus Coronary Intervention
- Keywords
- Percutaneous coronary intervention, Coronary artery perforation, Covered stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneus Coronary InterventionDevice
Covered Stent
| Study group | Role | What they receive |
|---|---|---|
| Consecutive patients treated with covered stents post PCI CAP | Not described Receives: Device: Percutaneus Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE)
MACE
Measured: 1 year
Secondary outcomes (4)
Stent Thrombosis (ST)
ST
Measured: 1 year
Cardiac Death
CV Death
Measured: 1 year
Target Lesion Revascularization (TLR)
TLR
Measured: 1 year
Myocardial Infarction (MI)
MI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Jan 2009
- Primary completion1 Nov 2019
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Wańha, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630314
- Sponsor's protocol ID
- 04
- Acronym
- CRACK
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural and 1-year Outcomes Following Large Vessel Coronary Artery Perforation Treated by Covered Stents Implantation: Multicentre CRACK Registry
- ClinicalTrials.gov ID
- NCT04630314
- Acronym / sponsor ID
- CRACK / 04
- Conditions
- Coronary Artery Perforation
- Keywords
- Percutaneous coronary intervention, Coronary artery perforation, Covered stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Covered stents have been mainly used for treatment of potentially life-threatening coronary artery perforation and coronary artery aneurysm. Prior studies suggest that the use of covered stents improves event-free survival, enabling a life-threatening situation to be managed without emergency surgery and with significantly reduced rates of mortality, cardiac tamponade, and major adverse cardiac events. Although the devices are used for a long time, very limited study has described procedural-related outcomes with this specific technology. We therefore want to report procedural, in-hospital and long term outcomes among patients treated with the covered stents.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients treated with covered stents post PCI CAP | – | Device: Percutaneus Coronary Intervention |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients
Key inclusion criteria (1 listed)
- Iatrogenic, peri-PCI CAP treated with covered stent implantation
Key exclusion criteria (2 listed)
- CAP caused due to other cause than PCI
- PCI of other vascular territories during the same procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneus Coronary InterventionCovered Stent | Device | Consecutive patients treated with covered stents post PCI CAP |
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: 1 year
MACE
4 secondary outcomes
Stent Thrombosis (ST)
Time frame: 1 year
Cardiac Death
Time frame: 1 year
Target Lesion Revascularization (TLR)
Time frame: 1 year
Myocardial Infarction (MI)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Perforation, run by Medical University of Silesia at 6 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.