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

Luzerner Kantonsspital

Status: Enrolling

Conditions: Stable Chronic Angina; Coronary Artery Disease; Coronary Restenosis; Angina, Stable; Coronary Arteriosclerosis; Angina Pectoris; Angina, Unstable; Coronary Artery Calcification; Coronary Disease; Stent Thrombosis

Treatments: Device: Sirolimus Eluting Balloon

Study type: Observational

Funder types: Other

Identifiers

NCT04988685

2021-00615

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject >18 years of age
• Patients with significant acute or chronic coronary de-novo lesions or ISR lesions requiring treatment using PCI
• Treatment with at least one DCB (device choice at the operator's discretion) In case of a patient with lesions treated at different procedural time, lesions will be separately collected and documented
• Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).

Exclusion criteria

• Patient is <18 years of age
• Patient unwilling or unable to provide informed consent
• pregnancy and lactation
• Indication for surgical revascularization

Trial design

2,000 participants in 1 patient group

Treatment

Description:

The project ́s main goal is to collect baseline, clinical and procedural data as well as to assess angiographic and clinical outcomes of CAD patients treated with contemporary DCBs.

Treatment:

Device: Sirolimus Eluting Balloon