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

NCT04988685 | Recruiting

• 1 other identifier: 2021-00615
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of target lesion failure (TLF) and target lesion revascularization (TLR)

  at 1 year

Secondary Outcomes (26)

• 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

Study Arms (1)

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

Interventions

Sirolimus Eluting Balloon DEVICE

PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon

Also known as: Paclitaxel Eluting Balloon

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Patient is \<18 years of age
• Patient unwilling or unable to provide informed consent
• pregnancy and lactation
• Indication for surgical revascularization

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

Luzerner Heart Centre

Lucerne, Canton of Lucerne, 6000, Switzerland

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Angina, Stable; Angina Pectoris; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Florim Cuculi, MD

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florim Cuculi, MD

CONTACT

+41412052134; florim.cuculi@luks.ch

Matthias Bossard, MD

CONTACT

+41412051477; matthias.bossard@luks.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Co-Investigator

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 3, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

CH (1)