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NCT06075602Recruiting

COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease

Source: ClinicalTrials.gov · Last updated 29 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
4 Oct 2023
Start date
1 Nov 2021
Primary completion date
31 Dec 2031
Lead sponsor
Luzerner Kantonsspital
NCT number
NCT06075602

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 1 Nov 2021 to the primary completion date, 31 Dec 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Patient is \<18 years of age

Other

  • The presence of any one of the following exclusion criteria will lead to exclusion of the patient.
  • Patient unwilling or unable to provide informed consent
  • Patients with no complex and calcified CAD

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lucerne Heart Centre
Coordinator of this site? Confirm its status
LucerneSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.