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

Sponsor

Luzerner Kantonsspital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04988685

Collaborator

(none)

1,000

Enrollment

Location

127

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis Coronary Arteriosclerosis Coronary Artery Calcification Stable Chronic Angina Angina Pectoris Angina, Stable Angina, Unstable Stent Thrombosis	Device: Sirolimus Eluting Balloon

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:

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)
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2031

Arms and Interventions

Arm	Intervention/Treatment
Treatment 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.	Device: Sirolimus Eluting Balloon PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon Other Names: Paclitaxel Eluting Balloon

Arm

Intervention/Treatment

Treatment

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.

Device: Sirolimus Eluting Balloon

PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon

Other Names:

Paclitaxel Eluting Balloon

Outcome Measures

Primary Outcome Measures

Rate of target lesion failure (TLF) and target lesion revascularization (TLR) [at 1 year]

Secondary Outcome Measures

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 new MI (NSTEMI / STEMI) [at 180 days, 1, 2 and 5 years]
Rate of TIA or stroke [at 180 days, 1, 2 and 5 years]
Rate of acute vessel closure [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 target lesion revascularization (TLR) [at 180 days, 1, 2 and 5 years]
Rate of target lesion failure (TLF) [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 cardiac death [at 180 days, 1, 2 and 5 years]
Rate of all myocardial infarction and TV-MI [at 180 days, 1, 2 and 5 years]
Rate of rehospitalization for recurrent angina [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 bleeding events (access site or non-access site related) according to the BARC classification [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 cardiogenic shock [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 major adverse limb events (MALE) [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 angina according to Canadian Cardiovascular Society (CCS) Score [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 periprocedural complications (e.g. coronary perforations, no-reflow) [at 180 days, 1, 2 and 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).