Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention - COMPLEX Registry.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 980
- Locations
- 1
- Primary Endpoint
- Target lesion revascularization (TLR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Major adverse cardiac events (MACE)(12 month)
- Procedural success(Peri-procedural)
Investigators
Sylwia Iwanczyk
Principal Investigator
Poznan University of Medical Sciences