NCT06075602 COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease
| NCT ID | NCT06075602 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luzerner Kantonsspital |
| Condition | Coronary Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2021-11-01 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Florim Cuculi, MD
PRINCIPAL INVESTIGATOR
Luzerner Kantonsspital
Frequently Asked Questions
Who can join the NCT06075602 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06075602 currently recruiting?
Yes, NCT06075602 is actively recruiting participants. Contact the research team at florim.cuculi@luks.ch for enrollment information.
Where is the NCT06075602 trial being conducted?
This trial is being conducted at Lucerne, Switzerland.
Who is sponsoring the NCT06075602 clinical trial?
NCT06075602 is sponsored by Luzerner Kantonsspital. The principal investigator is Florim Cuculi, MD at Luzerner Kantonsspital. The trial plans to enroll 5,000 participants.