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Recruiting

NCT Number: NCT07814157

PCI Registry Basel

This registry aims to learn more about the best ways to treat coronary artery disease. Information from routine medical care will be collected to compare different treatment approaches, including drug-eluting stents, drug-coated balloons (DCB), and bioresorbable scaffolds (BRS), which gradually dissolve over time. The registry will include people with coronary artery disease who receive an intervention (percutaneous coronary intervention), including those undergoing more complex procedures. By studying treatment outcomes over time, the Registry aims to better understand which therapies work best for different groups of patients and to improve future care for people with coronary artery disease.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location status: Recruiting

Location contact

Gregor Leibundgut, Prof. Dr. med.

CONTACT

[email protected]

(0)61 556 58 18 ext. 0041

Gregor Leibundgut, Prof. Dr. med.

PRINCIPAL_INVESTIGATOR

Jasper Boeddinghaus, PD Dr. med.

CONTACT

[email protected]

(0)61 328 78 97 ext. 0041

Jasper Boeddinghaus, PD Dr. med.

PRINCIPAL_INVESTIGATOR

About this study

The PCI Registry Basel is established to systematically collect real-world data on all patients (≥18 years) undergoing percutaneous coronary interventions (PCI) at the University Hospital Basel. The primary purpose of the registry is to investigate the best treatment strategies in patients with coronary artery disease (CAD) and their associated outcomes in routine clinical practice, including complex procedures (e.g. chronic total occlusions (CTO), bifurcation lesions, left main interventions), the use of drug-coated balloons (DCB) and bioresorbable scaffolds (BRS), as well as standard drug-eluting stent (DES) implantation.

Data are derived retrospectively from routine clinical practice at the University Hospital Basel. Relevant procedural, clinical, and follow-up information is extracted from existing sources such as the catheterization lab reports, and the electronic health record (Cardioapp). No additional data collection or invasive study-specific interventions are performed for the purpose of this registry.

Where applicable, data from previous research projects or registries may also be incorporated, provided that all legal and ethical requirements are satisfied. All data will be pseudonymised before analysis. A secure decoding key linking registry numbers to patient identifiers is kept separately and is accessible only to authorized personnel under the responsibility of the Principal Investigator.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients treated at the University Hospital Basel

  • Undergoing complex PCI (e.g. left main, bifurcation, multivessel PCI, rotational atherectomy or other calcium modification, complex anatomy). The definition complex will be a clinical/ procedural/ anatomical definition made by the operator.
  • Undergoing CTO or CHIP (Complex High-risk Indicated Patient) procedures
  • Treated with a DCB strategy
  • Treated with a BRS

Exclusion criteria

  • Patients under 18 years of age

Treatment and study plan

Primary outcomes

  1. Target Vessel Failure (TVF)

    Time frame: Through study completion, an average of 1 year

    Composite endpoint defined as the occurrence of cardiovascular death, target vessel myocardial infarction, or unplanned target vessel revascularisation.

Other outcomes

  1. All-Cause Mortality

    Time frame: Through study completion, an average of 1 year

    Death from any cause as documented in the available medical records.

  2. Cardiovascular Mortality

    Time frame: Through study completion, an average of 1 year

    Death attributed to a cardiovascular cause as documented in the medical records.

  3. Occurrence of Myocardial Infarction

    Time frame: Through study completion, an average of 1 year

    Documented occurrence of myocardial infarction in the medical records.

  4. Procedural Success Rate

    Time frame: Through study completion, an average of 1 year

    Proportion of PCI procedures meeting the predefined criteria for procedural success.

  5. Procedural Complication Rate

    Time frame: Through study completion, an average of 1 year

    Proportion of PCI procedures with documented procedural complications

  6. Rate of Rescue Stenting

    Time frame: Through study completion, an average of 1 year

    Proportion of PCI procedures requiring unplanned rescue stent implantation.

  7. Unplanned hospitalisation for angina

    Time frame: Through study completion, an average of 1 year

    Unplanned hospitalisation due to angina as documented in the medical records

  8. Unplanned hospitalisation for heart failure

    Time frame: Through study completion, an average of 1 year

    Unplanned hospitalisation due to heart failure, as documented in the medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregor Leibundgut, Prof. Dr. med.

CONTACT

[email protected]

(0)61 556 58 18 ext. 0041

Jasper Boeddinghaus, PD Dr. med.

CONTACT

[email protected]

(0)61 328 78 97 ext. 0041

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

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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