Clinical trial NCT04988685: SIROOP Registry - a Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated with SIROlimus or Paclitaxel Eluting Balloon Catheters
Official title: SIROOP Registry - a Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated with SIROlimus or Paclitaxel Eluting Balloon Catheters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Coronary Arteriosclerosis
Coronary Artery Calcification
Stable Chronic Angina
Angina Pectoris
Angina, Stable
Angina, Unstable
Stent Thrombosis
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2021-08-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Rate of target lesion failure (TLF) and target lesion revascularization (TLR)
timeFrame: at 1 year
Secondary outcomes:
measure: Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) (including new MI, TLR or cardiovascular death)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of MACE
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of new MI (NSTEMI / STEMI)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of TIA or stroke
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of acute vessel closure
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of stent thrombosis or ISR
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of target vessel revascularization (TVR)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of target lesion revascularization (TLR)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of target lesion failure (TLF)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of ischemia driven TLR
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of all-cause death
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of cardiac death
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of all myocardial infarction and TV-MI
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of rehospitalization for recurrent angina
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of hospitalization for HF
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of rehospitalization for HF, resuscitated cardiac arrest or implantable cardioverter- defibrillator (ICD) implantation
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of bleeding events (access site or non-access site related) according to the BARC classification
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of vascular complications (according to VARC criteria)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of cardiogenic shock
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of acute renal failure/ contrast-induced nephropathy (CIN)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of new ventricular arrhythmias
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of major adverse limb events (MALE)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of new York Heart Association (NYHA) class
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of angina according to Canadian Cardiovascular Society (CCS) Score
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of procedural success (final diameter stenosis < 30% without flow-limiting dissections)
timeFrame: at 180 days, 1, 2 and 5 years
measure: Rate of periprocedural complications (e.g. coronary perforations, no-reflow)
timeFrame: at 180 days, 1, 2 and 5 years
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Luzerner Heart Centre
Study officials:
affiliation: Luzerner Kantonsspital
name: Florim Cuculi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.