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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06075602
Other study ID # 2021-01290
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 31, 2031

Study information

Verified date October 2023
Source Luzerner Kantonsspital
Contact Florim Cuculi, MD
Phone +41412052154
Email florim.cuculi@luks.ch
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
Switzerland Lucerne Heart Centre Lucerne

Sponsors (1)

Lead Sponsor Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Major adverse cardiac and cerebrovascular events (MACCE) 1 year
Secondary Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) 1 year, 2 years, 5 years and 10 years
Secondary Rate of acute vessel closure 1 year, 2 years, 5 years and 10 years
Secondary Rate of target vessel revascularization (TVR) 1 year, 2 years, 5 years and 10 years
Secondary Rate of target lesion revascularization (TLR) 1 year, 2 years, 5 years and 10 years
Secondary Rate of target lesion failure (TLF) 1 year, 2 years, 5 years and 10 years
Secondary Rate of ischemia driven TLR 1 year, 2 years, 5 years and 10 years
Secondary Rate of new AMI (NSTEMI/STEMI) 1 year, 2 years, 5 years and 10 years
Secondary Rate of TIA or stroke 1 year, 2 years, 5 years and 10 years
Secondary Rate of cardiovascular mortality 1 year, 2 years, 5 years and 10 years
Secondary Rate of all-cause mortality 1 year, 2 years, 5 years and 10 years
Secondary Rate of bleeding events (access site or non-access site related) according to the BARC classification. 1 year, 2 years, 5 years and 10 years
Secondary Rate of vascular complications (according to VARC criteria) 1 year, 2 years, 5 years and 10 years
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