NCT04988685

SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Luzerner Kantonsspital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Disease
• Coronary Artery Disease
• Coronary Restenosis
• Coronary Arteriosclerosis
• Coronary Artery Calcification
• Stable Chronic Angina
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Stent Thrombosis

Interventions

Type	Name	Description
DEVICE	Sirolimus Eluting Balloon	PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-12-31
• Completion: 2031-12-31
• First posted: 2021-08-03
• Last updated: 2024-10-29

Locations

1 site across 1 country: Switzerland