NCT06131333|Completed
Complex CAD Treated With PCI With DES Implantation.
Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention - COMPLEX Registry.
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Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention - COMPLEX Registry.
Sponsor study identifier
observational
980
1 country
1
Study Start
January 1, 2022
Actual (reported)Primary Completion
October 30, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)COMPLEX Registry is an investigator-initiated, retrospective, high-volume Polish single-center clinical registry enrolling 980 consecutive patients with complex coronary artery lesions treated percutaneously between September 2015 and December 2021. All data were collected prospectively as regards the clinical and technical endpoints. The study aimed to assess the safety and efficacy of new-generation, thin-struts DES in patients with complex CAD at long-term clinical follow-up. The primary endpoint of the study was the occurrence of TLR during follow-up. Secondary endpoints were a procedural success and the occurrence of MACE, including all-cause death, MI, or TLR.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2022
Actual (reported)October 30, 2022
Actual (reported)December 31, 2022
Actual (reported)October 26, 2023
Actual (reported)November 14, 2023
Actual (reported)Target lesion revascularization (TLR)
During the 12-month follow-up, the incidence of TLR in patients included in the study will be reported. TLR was defined as revascularization post-stenting within the stent or within the 5-mm borders adjacent to the stent.
12 months
Major adverse cardiac events (MACE)
12 month
Procedural success
Peri-procedural
All consecutive patients with complex coronary artery disease (CAD) were treated with percutaneous coronary intervention (PCI). The complexity of CAD was defined as having at least one of the following characteristics: chronic total occlusion (CTO), lesion length \>40 mm, severe calcification assessed by angiography or intravascular imaging examination, multivessel PCI during the same intervention, or true bifurcation defined as any lesion involving both the main vessel (MV), proximal or distal and the ostium of the side branch (SB) (Medina 1,1,1; 1,0,1; or 0,1,1).
PCI was performed according to the general and local recommendations. The choice of DES among the new generation DES and the decision on procedure optimization belonged to the operator.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients with symptomatic CAD, including chronic coronary syndromes (CCS) and acute coronary syndromes (ACS), qualified for PCI and meeting the criteria for complex CAD were included in the analysis.
Poznan University of Medical Sciences, Poland
Poznan, Wielkopolska, 61-701, Poland
980 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2023
First Posted
November 14, 2023
Study Start
January 1, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 30, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
November 14, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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