COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients… (NCT06075602) | Clinical Trial Compass
RecruitingNot Applicable
COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease
Switzerland5,000 participantsStarted 2021-11-01
Plain-language summary
The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and/ or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques/ devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject \>18 years of age
* Individuals presenting with chronic, complex and/or calcified CAD and requiring PCI or CABG
* Complex coronary artery disease / lesions must include at least one of the following attributes:
* Long and/ or heavily calcified coronary lesions
* In-stent restenosis
* Chronic total occlusions (CTO)
* Left main lesions
* Bifurcation lesions
* Bypass graft lesions
* Small vessel disease / coronary microvascular dysfunction (e.g. not amenable to PCI)
* Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).
Exclusion Criteria:
The presence of any one of the following exclusion criteria will lead to exclusion of the patient.
* Patient is \<18 years of age
* Patient unwilling or unable to provide informed consent
* Patients with no complex and calcified CAD
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Major adverse cardiac and cerebrovascular events (MACCE)