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

Recruiting

• Conditions: Coronary Artery Disease; Coronary Artery Calcification; Angina, Stable; Coronary Arteriosclerosis; Stable Chronic Angina; Angina Pectoris; Stent Thrombosis; Coronary Restenosis; Coronary Disease; Angina, Unstable
• Interventions: Device: Sirolimus Eluting Balloon

• Registration Number: NCT04988685
• Lead Sponsor: Luzerner Kantonsspital

Brief 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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-07-25
• Study First Submitted QC: 2021-07-25
• Study First Posted: 2021-08-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-29
• Primary Completion: 2026-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Sirolimus Eluting Balloon	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.

Primary Outcome Measures

Name	Time	Method
Rate of target lesion failure (TLF) and target lesion revascularization (TLR)	at 1 year

Secondary Outcome Measures

Name	Time	Method
Rate of all myocardial infarction and TV-MI	at 180 days, 1, 2 and 5 years
Rate of target lesion revascularization (TLR)	at 180 days, 1, 2 and 5 years
Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) (including new MI, TLR or cardiovascular death)	at 180 days, 1, 2 and 5 years
Rate of MACE	at 180 days, 1, 2 and 5 years
Rate of stent thrombosis or ISR	at 180 days, 1, 2 and 5 years
Rate of target vessel revascularization (TVR)	at 180 days, 1, 2 and 5 years
Rate of ischemia driven TLR	at 180 days, 1, 2 and 5 years
Rate of all-cause death	at 180 days, 1, 2 and 5 years
Rate of TIA or stroke	at 180 days, 1, 2 and 5 years
Rate of target lesion failure (TLF)	at 180 days, 1, 2 and 5 years
Rate of major adverse limb events (MALE)	at 180 days, 1, 2 and 5 years
Rate of procedural success (final diameter stenosis < 30% without flow-limiting dissections)	at 180 days, 1, 2 and 5 years
Rate of new MI (NSTEMI / STEMI)	at 180 days, 1, 2 and 5 years
Rate of acute vessel closure	at 180 days, 1, 2 and 5 years
Rate of cardiac death	at 180 days, 1, 2 and 5 years
Rate of rehospitalization for recurrent angina	at 180 days, 1, 2 and 5 years
Rate of acute renal failure/ contrast-induced nephropathy (CIN)	at 180 days, 1, 2 and 5 years
Rate of new ventricular arrhythmias	at 180 days, 1, 2 and 5 years
Rate of angina according to Canadian Cardiovascular Society (CCS) Score	at 180 days, 1, 2 and 5 years
Rate of cardiogenic shock	at 180 days, 1, 2 and 5 years
Rate of new York Heart Association (NYHA) class	at 180 days, 1, 2 and 5 years
Rate of hospitalization for HF	at 180 days, 1, 2 and 5 years
Rate of rehospitalization for HF, resuscitated cardiac arrest or implantable cardioverter- defibrillator (ICD) implantation	at 180 days, 1, 2 and 5 years
Rate of vascular complications (according to VARC criteria)	at 180 days, 1, 2 and 5 years
Rate of periprocedural complications (e.g. coronary perforations, no-reflow)	at 180 days, 1, 2 and 5 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification	at 180 days, 1, 2 and 5 years

Trial Locations

Locations (1)

Luzerner Heart Centre; 🇨🇭 Lucerne, Switzerland