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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Disease; Angina, Stable; Angina Pectoris; Coronary Arteriosclerosis; Angina, Unstable; Coronary Artery Calcification; Stent Thrombosis; Coronary Restenosis; Stable Chronic Angina
• Intervention / Treatment: 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:

  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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Matthias Bossard, MD; Phone Number: +41412051477; Email: matthias.bossard@luks.ch
• Study Contact Backup: Name: Florim Cuculi, MD; Phone Number: +41412052134; Email: florim.cuculi@luks.ch

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6000
    • Recruiting
    • Luzerner Heart Centre
    • Contact: Florim Cuculi, MD; Phone Number: +41412052134; Email: florim.cuculi@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This registry will recruit consecutive patients treated with either DCB alone or a hybrid strategy (metallic stent plus DCB). Ideally any patient treated with a DCB will be included in the present registry, either presenting with a de-novo coronary lesion (either elective or urgent procedure), with a ST or ISR.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of target lesion failure (TLF) and target lesion revascularization (TLR)	at 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Collaborators: University Hospital, Geneva
• Investigators: Principal Investigator: Florim Cuculi, MD, Luzerner Kantonsspital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Embolism and Thrombosis; Arterial Occlusive Diseases; Chest Pain; Coronary Stenosis; Thrombosis; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Coronary Disease; Angina Pectoris; Angina, Stable; Angina, Unstable; Coronary Restenosis; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Sirolimus; Paclitaxel
• Other Study ID Numbers: 2021-00615

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No