Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04988685

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Coronary Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Arteriosclerosis Coronary Artery Calcification Coronary Artery Disease Coronary Restenosis Coronary Stenosis Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Chronic Angina Stent Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luzerner Heart Centre

Lucerne, Canton of Lucerne, 6000, Switzerland

Location status: Recruiting

Location contact

Florim Cuculi, MD

CONTACT

[email protected]

+41412052134

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sirolimus Eluting Balloon

Device

PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon

Other names: Paclitaxel Eluting Balloon

Primary outcomes

  1. Rate of target lesion failure (TLF) and target lesion revascularization (TLR)

    Time frame: at 1 year

Secondary outcomes

  1. Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) (including new MI, TLR or cardiovascular death)

    Time frame: at 180 days, 1, 2 and 5 years

  2. Rate of MACE

    Time frame: at 180 days, 1, 2 and 5 years

  3. Rate of new MI (NSTEMI / STEMI)

    Time frame: at 180 days, 1, 2 and 5 years

  4. Rate of TIA or stroke

    Time frame: at 180 days, 1, 2 and 5 years

  5. Rate of acute vessel closure

    Time frame: at 180 days, 1, 2 and 5 years

  6. Rate of stent thrombosis or ISR

    Time frame: at 180 days, 1, 2 and 5 years

  7. Rate of target vessel revascularization (TVR)

    Time frame: at 180 days, 1, 2 and 5 years

  8. Rate of target lesion revascularization (TLR)

    Time frame: at 180 days, 1, 2 and 5 years

  9. Rate of target lesion failure (TLF)

    Time frame: at 180 days, 1, 2 and 5 years

  10. Rate of ischemia driven TLR

    Time frame: at 180 days, 1, 2 and 5 years

  11. Rate of all-cause death

    Time frame: at 180 days, 1, 2 and 5 years

  12. Rate of cardiac death

    Time frame: at 180 days, 1, 2 and 5 years

  13. Rate of all myocardial infarction and TV-MI

    Time frame: at 180 days, 1, 2 and 5 years

  14. Rate of rehospitalization for recurrent angina

    Time frame: at 180 days, 1, 2 and 5 years

  15. Rate of hospitalization for HF

    Time frame: at 180 days, 1, 2 and 5 years

  16. Rate of rehospitalization for HF, resuscitated cardiac arrest or implantable cardioverter- defibrillator (ICD) implantation

    Time frame: at 180 days, 1, 2 and 5 years

  17. Rate of bleeding events (access site or non-access site related) according to the BARC classification

    Time frame: at 180 days, 1, 2 and 5 years

  18. Rate of vascular complications (according to VARC criteria)

    Time frame: at 180 days, 1, 2 and 5 years

  19. Rate of cardiogenic shock

    Time frame: at 180 days, 1, 2 and 5 years

  20. Rate of acute renal failure/ contrast-induced nephropathy (CIN)

    Time frame: at 180 days, 1, 2 and 5 years

  21. Rate of new ventricular arrhythmias

    Time frame: at 180 days, 1, 2 and 5 years

  22. Rate of major adverse limb events (MALE)

    Time frame: at 180 days, 1, 2 and 5 years

  23. Rate of new York Heart Association (NYHA) class

    Time frame: at 180 days, 1, 2 and 5 years

  24. Rate of angina according to Canadian Cardiovascular Society (CCS) Score

    Time frame: at 180 days, 1, 2 and 5 years

  25. Rate of procedural success (final diameter stenosis < 30% without flow-limiting dissections)

    Time frame: at 180 days, 1, 2 and 5 years

  26. Rate of periprocedural complications (e.g. coronary perforations, no-reflow)

    Time frame: at 180 days, 1, 2 and 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Florim Cuculi, MD

CONTACT

[email protected]

+41412052134

Matthias Bossard, MD

CONTACT

[email protected]

+41412051477

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Collaborators

  • University Hospital, Geneva

Registry information

Acronym: SIROOP

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Aug 3, 2021
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.