Coronary Artery DiseaseNCT03212378
Safety and Efficacy of "Standardized" CHIP
An observational study of Coronary Artery Disease, run by University Hospital, Essen at 1 site in Germany.
Trial summary
In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- percutaneous coronary interventions
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2016to 30 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of consecutive high-risk subjects indicated for percutaneous complex high-risk interventional procedures.
Who may be able to join
- Signed Informed Consent
- Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
Who cannot join
- Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.5.)
- History of recent (within 1 month) stroke or TIA
- Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of "Standardized" Complex High-risk Interventional Procedures - a New Pathway for Protected Percutaneous Coronary Interventions
In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in selected high-risk patients.
The objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (CHIP).
- Conditions
- Coronary Artery Disease
- Being tested
- percutaneous coronary interventions
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionsOther
Percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| CHIP 1 - low risk patients | Not described Receives: Other: percutaneous coronary interventions | |
| CHIP 2 - medium risk patients | Not described Receives: Other: percutaneous coronary interventions | |
| CHIP 3 - high risk patients | Not described Receives: Other: percutaneous coronary interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & feasibility
Accurate classification of patients into the respective group defined by the necessity of upgrade
Measured: 30 days
Hemodynamic Compromise (HC)
Freedom from hemodynamic compromise during PCI procedure defined as: mean arterial pressure (MAP) not decreasing to values below 60 mmHg for more than 10 minutes during the PCI procedure
Measured: 30 days.
Secondary outcomes (2)
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
A composite rate of the following intra-procedural and post-procedural Major Adverse Cardiac and Cerebrovascular Events (MACCE) events defined as death, new myocardial infarction, or cerebrovascular accident up to 30 days post index procedure.
Measured: 30 days
Adverse events
Rates of acute kidney injury ([AKI] according to KDIGO), sepsis, vascular complications (defined by Valve Academic Research Consortium 2 [VARC 2]), bleeding (defined by Bleeding Academic Research Consortium [BARC]) and coronary complications.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadi Al-Rashid, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212378
- Sponsor's protocol ID
- FA_2017_01
- Status last verified
- Nov 2023
- First submitted
- 3 Jul 2017
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of "Standardized" Complex High-risk Interventional Procedures - a New Pathway for Protected Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT03212378
- Acronym / sponsor ID
- FA_2017_01
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Jul 2017 (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.
In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in selected high-risk patients.
The objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (CHIP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHIP 1 - low risk patients | – | Other: percutaneous coronary interventions |
| CHIP 2 - medium risk patients | – | Other: percutaneous coronary interventions |
| CHIP 3 - high risk patients | – | Other: percutaneous coronary interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of consecutive high-risk subjects indicated for percutaneous complex high-risk interventional procedures.
Key inclusion criteria (2 listed)
- Signed Informed Consent
- Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
Key exclusion criteria (3 listed)
- Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.5.)
- History of recent (within 1 month) stroke or TIA
- Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors
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 |
|---|---|---|
| percutaneous coronary interventionsPercutaneous coronary intervention. | Other | CHIP 1 - low risk patients, CHIP 2 - medium risk patients, CHIP 3 - high risk patients |
Primary outcome
Safety & feasibility
Time frame: 30 days
Accurate classification of patients into the respective group defined by the necessity of upgrade
Hemodynamic Compromise (HC)
Time frame: 30 days.
Freedom from hemodynamic compromise during PCI procedure defined as: mean arterial pressure (MAP) not decreasing to values below 60 mmHg for more than 10 minutes during the PCI procedure
2 secondary outcomes
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 30 days
Adverse events
Time frame: 30 days
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 29 Nov 2023.
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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.
1 site 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 Disease, run by University Hospital, Essen at 1 site in Germany.
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 2 inclusion and 3 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Safety & feasibility (time frame: 30 days). The study lists 2 primary outcomes in all. 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 29 Nov 2023.