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

Coronary Artery Disease Clinical Trial

— SIROOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04988685
• Other study ID #: 2021-00615
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 31, 2031

Study information

• Verified date: October 2023
• Source: Luzerner Kantonsspital
• Contact: Florim Cuculi, MD
• Phone: +41412052134
• Email: florim.cuculi[@]luks.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Sirolimus Eluting Balloon
PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon

Locations

Country	Name	City	State
Switzerland	Luzerner Heart Centre	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

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