Complex CAD Treated With PCI With DES Implantation.

NCT06131333 | Completed

• 1 other identifier: 821/23
• Study Type: observational
• Target: 980
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complex Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Major adverse cardiac events (MACE)

  12 month

• Procedural success

  Peri-procedural

Study Arms (1)

Complex PCI

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).

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

Interventions

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.

Complex PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences, Poland

Poznan, Wielkopolska, 61-701, Poland

Location

MeSH Terms

Interventions

Percutaneous Coronary Intervention; Drug Implants

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 14, 2023
• Study Start: January 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

PL (1)