Registry to track management and outcomes of patients with complex coronary artery disease
COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease
This study is tracking how well different treatments for complex coronary artery disease work in patients who have had procedures like stents or bypass surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Luzerner Kantonsspital Academic / other |
| Locations | 1 site (Lucerne, Canton of Lucerne) |
| Trial ID | NCT06075602 on ClinicalTrials.gov |
What this trial studies
The COMPLEX Registry aims to collect both baseline and clinical data from patients who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for complex and calcified coronary artery disease. This observational study will analyze procedural outcomes and complications, comparing results across different clinical subgroups. It will also assess the impact of various PCI techniques and CABG strategies on cardiovascular outcomes, including short and long-term clinical results. Data will be collected prospectively and retrospectively to provide a comprehensive overview of patient management and outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with chronic, complex, and/or calcified coronary artery disease requiring PCI or CABG.
Not a fit: Patients under 18 or those without complex and calcified coronary artery disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment strategies and outcomes for patients with complex coronary artery disease.
How similar studies have performed: Other studies have shown success in tracking outcomes for coronary interventions, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lucerne, Canton of Lucerne
- Lucerne Heart Centre — Lucerne, Canton of Lucerne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Florim Cuculi, MD — Luzerner Kantonsspital
- Study coordinator: Florim Cuculi, MD
- Email: florim.cuculi@luks.ch
- Phone: +41412052154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.