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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLuzerner Kantonsspital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Subject >18 years of age

Individuals presenting with chronic, complex and/or calcified CAD and requiring PCI or CABG

Long and/ or heavily calcified coronary lesions

In-stent restenosis

Disqualifiers

Patient is <18 years of age

Patient unwilling or unable to provide informed consent

Patients with no complex and calcified CAD

Trial population

In an all-comers design, virtually any CAD patient with complex and/ or calcified coronary artery disease treated with PCI or CABG at the Heart Center of the Luzerner Kantonsspital (LUKS) and giving consent may be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Impact of current PCI techniques/ devices in complex coronary artery lesions

    Device

    To evaluate the impact of current PCI techniques/devices, but also CABG strategies, in patients with complex coronary artery lesions

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Treatment1 intervention

Trial outcomes

Primary outcomes

1

Rate of Major adverse cardiac and cerebrovascular events (MACCE)

Time frame
1 year

Secondary outcomes

1

Rate of combination of major adverse cardiac and cerebrovascular events (MACCE)

Time frame
1 year, 2 years, 5 years and 10 years
2

Rate of acute vessel closure

Time frame
1 year, 2 years, 5 years and 10 years
3

Rate of target vessel revascularization (TVR)

Time frame
1 year, 2 years, 5 years and 10 years
4

Rate of target lesion revascularization (TLR)

Time frame
1 year, 2 years, 5 years and 10 years

Other outcomes

Sponsors and contacts

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