Status:

RECRUITING

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

Lead Sponsor:

Luzerner Kantonsspital

Conditions:

Coronary Disease

Coronary Artery Disease

Eligibility:

All Genders

18+ years

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 chro...

Detailed Description

a. PCI cohort - Periprocedural outcomes/ complications to be analyzed represent: final result (e.g. TIMI flow), stent expansion, dissections, perforations, and prevalence of thrombus (assessed by angi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2031

Estimated Enrollment :

5000 Patients enrolled

Trial Details

Trial ID

NCT06075602

Start Date

November 1 2021

End Date

December 31 2031

Last Update

October 29 2024

Active Locations (1)

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1

Lucerne Heart Centre

Lucerne, Canton of Lucerne, Switzerland, 6000