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Completed

NCT Number: NCT06131333

Complex CAD Treated With PCI With DES Implantation.

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.

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Key information

Conditions

Complex Coronary Artery Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Poznan University of Medical Sciences, Poland

Poznan, Wielkopolska, 61-701, Poland

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For the inclusion of patients in this study, 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).

Exclusion criteria

  • left main stem
  • PCI treated during index procedure;
  • cardiogenic shock,
  • thrombolysis before PCI;
  • 12-month follow-up not available

Treatment and study plan

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation

Procedure

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.

Primary outcomes

  1. Target lesion revascularization (TLR)

    Time frame: 12 months

    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.

Secondary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: 12 month

    During the 12-month follow-up, the incidence of MACE in patients included in the study will be assessed. Major adverse cardiac event composed of all-cause death, myocardial infarction (MI), or TLR.

  2. Procedural success

    Time frame: Peri-procedural

    Procedural success was defined as angiographic success in the absence of in-hospital major events including death, MI, need for TLR, stroke, vascular access site complications, and contrast agent nephropathy.

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention - COMPLEX Registry.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2023
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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