SIROOP Registry - a Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated with SIROlimus or Paclitaxel Eluting Balloon Catheters

Last updated: October 27, 2024
Sponsor: Luzerner Kantonsspital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Chest Pain

Vascular Diseases

Treatment

Sirolimus Eluting Balloon

Clinical Study ID

NCT04988685
2021-00615
  • Ages > 18
  • All Genders

Study Summary

The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject >18 years of age

  • Patients with significant acute or chronic coronary de-novo lesions or ISR lesionsrequiring treatment using PCI

  • Treatment with at least one DCB (device choice at the operator's discretion) In caseof a patient with lesions treated at different procedural time, lesions will beseparately collected and documented

  • Subjects must be willing to sign a patient informed consent (PIC) or must havesigned the General Consent (GK).

Exclusion

Exclusion Criteria:

  • Patient is <18 years of age

  • Patient unwilling or unable to provide informed consent

  • pregnancy and lactation

  • Indication for surgical revascularization

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Sirolimus Eluting Balloon
Phase:
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2031

Study Description

Objectives in detail:

  • To evaluate procedural success, efficacy, performance and clinical outcomes among various patient cohorts, who undergo PCI using currently available DCBs:

    1. Periprocedural outcomes/complications, which will be analyzed, include: final result (e.g. residual stenosis, TIMI flow), dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging)

    2. Short and long-term clinical outcomes of interest comprise among others: new MI, unstable angina (UA), target lesion failure, target vessel revascularization, target lesion failure/ revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death.

  • To describe procedural and clinical performance of various DCB, either alone or in combination with other stent and coronary scaffold devices

  • To identify optimal strategies for lesion preparation in cases treated with DCB

  • To identify possible predictors for TLR after treatment with DCB

  • To describe early and late angiographic and OCT-findings among coronary artery disease (CAD) patients treated with DCB and/or various metallic stent and scaffold devices

  • To evaluate the impact of different antithrombotic regimens on patient's clinical outcomes

  • To study procedural and clinical outcomes among CAD patients requiring hemodynamic support using mechanical devices.

  • To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.

Connect with a study center

  • Luzerner Heart Centre

    Lucerne, 6000
    Switzerland

    Active - Recruiting

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