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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2031-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon

NCT03242096

Coronary Restenosis

COMPLETED NA

Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter

NCT03908450

Coronary Artery Disease

COMPLETED NA

Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon

NCT06866756

Coronary Arterial Disease (CAD)

RECRUITING

Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions

NCT00233714

Coronary Artery Disease

COMPLETED PHASE1/PHASE2

Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization

NCT00297661

Coronary Heart Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Sirolimus Eluting Balloon

Intervention Type DEVICE

PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sirolimus Eluting Balloon

PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Paclitaxel Eluting Balloon

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No