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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

• 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]
• Rate of MACE [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of new MI (NSTEMI / STEMI) [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of TIA or stroke [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of acute vessel closure [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of stent thrombosis or ISR [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of target vessel revascularization (TVR) [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of target lesion revascularization (TLR) [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of target lesion failure (TLF) [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of ischemia driven TLR [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of all-cause death [Time frame: at 180 days, 1, 2 and 5 years]
• Rate of cardiac death [Time frame: at 180 days, 1, 2 and 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Switzerland · 1 center

• Luzerner Heart Centre — Lucerne

Publications

• Cioffi GM, Madanchi M, Attinger-Toller A, Bossard M, Cuculi F. Pushing the Boundaries: Drug-Coated Balloons to Treat a Calcified and Thrombotic Lesion in Acute Coronary Syndrome. Am J Case Rep. 2022 Oct 5;23:e936950. doi: 10.12659/AJCR.936950. PMID 36196027
• Madanchi M, Cioffi GM, Attinger-Toller A, Seiler T, Somm S, Koch T, Tersalvi G, Wolfrum M, Moccetti F, Toggweiler S, Kobza R, Levine MB, Garcia-Garcia HM, Bossard M, Cuculi F. Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon. Cardiol J. 2022;29(6):906-916. doi: 10.5603/CJ.a2022.0106. Epub 2022 Nov 17. PMID 36385601
• Madanchi M, Attinger-Toller A, Gjergjizi V, Majcen I, Cioffi GM, Epper A, Gnan E, Koch T, Zhi Y, Cuculi F, Bossard M. Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon. Front Cardiovasc Med. 2024 Feb 13;11:1316580. doi: 10.3389/fcvm.2024.1316580. eCollection 2024. PMID 38414923
• Madanchi M, Bossard M, Majcen I, Cioffi GM, Ferraro F, Gnan E, Gjergjizi V, Zhi Y, Bade V, Wolfrum M, Moccetti F, Toggweiler S, Attinger-Toller A, Cuculi F. Outcomes following coronary chronic total occlusion revascularization with drug-coated balloons. J Invasive Cardiol. 2024 Mar;36(3). doi: 10.25270/jic/23.00260. PMID 38441987

Identifiers

NCT: NCT04988685 · 2021-00615

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗