Actively Recruiting

Age: 18Years +
All Genders
ID06075602

COMPLEX Registry: Prospective Study on Management and Outcomes of Patients with Complex and Calcified Coronary Artery Disease

Led by Luzerner Kantonsspital · Updated on 2024-10-29

5000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting detailed information about patients with complex and/or calcified chronic coronary artery disease (CAD) who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), as well as those managed medically. The study aims to compare clinical outcomes among these treatment groups and to understand how different PCI devices and CABG techniques affect cardiovascular health. It also examines patient subgroups such as those with diabetes or different ages and genders, evaluating their treatment differences and outcomes. The study observes patients receiving PCI, CABG, or medical management, gathering data on procedural results like blood flow and device performance in PCI, surgical details in CABG, and medical therapy regimens in conservatively managed patients. It analyzes short and long-term outcomes, including heart attacks, strokes, heart failure, bleeding, and death. The study also investigates predictors of treatment success or failure, economic aspects, and non-invasive testing methods. Participants provide baseline and clinical data and are followed over time to assess major adverse cardiac and cerebrovascular events (MACCE) up to 10 years after treatment. Researchers collect information on repeat procedures, hospitalizations, and complications through clinical evaluations. The study monitors safety and treatment effects continuously, aiming to improve understanding of how different management strategies impact patients with complex CAD.

CONDITIONS

Brief Title

COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Diagnosed with chronic, complex, and/or calcified coronary artery disease
  • Requires PCI or CABG treatment
  • Presence of at least one complex lesion type such as long or heavily calcified lesions, in-stent restenosis, chronic total occlusions, left main lesions, bifurcation lesions, bypass graft lesions, or small vessel disease
  • Willing to sign patient informed consent or has signed general consent
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Unable or unwilling to provide informed consent
  • Does not have complex or calcified coronary artery disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Procedure day and immediate peri-procedural period

Participants who undergo PCI or CABG procedures are observed during the implementation of current PCI techniques, devices, and surgical strategies for complex coronary artery lesions.

1 visit on procedure day

Long-term Monitoring

Duration - Up to 10 years

Participants are followed to assess clinical outcomes including cardiac events, revascularization, complications, and mortality over time.

Follow-up visits at 1 year, 2 years, 5 years, and 10 years

Trial Site Locations

Total: 1 location

1

Lucerne Heart Centre

Lucerne, Canton of Lucerne, Switzerland, 6000

Actively Recruiting

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Research Team

F

Florim Cuculi, MD

M

Matthias Bossard, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Long-term outcomes after treatment of in-stent restenosis using the Absorb everolimus-eluting bioresorbable scaffold.

Mehdi Madanchi, Giacomo Maria Cioffi, Adrian Attinger-Toller...

https://pubmed.ncbi.nlm.nih.gov/34518287

Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry.

Natalia Pinilla-Echeverri, Matthias Bossard, Ali Hillani...

https://pubmed.ncbi.nlm.nih.gov/36907698

Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds-Insights From an All-Comer Registry.

Matthias Bossard, Mehdi Madanchi, Dardan Avdijaj...

https://pubmed.ncbi.nlm.nih.gov/35498044