Coronary DiseaseSIROOPNCT04988685
SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters
An observational study of Coronary Disease and Coronary Artery Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- Sirolimus Eluting Balloon
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2021to 31 Dec 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Patient is <18 years of age
- Patient unwilling or unable to provide informed consent
- pregnancy and lactation
- Indication for surgical revascularization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Heart Centre
Lucerne, Canton of Lucerne, 6000
Florim Cuculi, MD, +41412052134, florim.cuculi@luks.ch
About this study
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.
Read the 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:
- 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.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary Arteriosclerosis, Coronary Artery Calcification, Stable Chronic Angina
- Being tested
- Sirolimus Eluting Balloon
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Angina, Stable, Angina Pectoris, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus Eluting BalloonDevice
Also called Paclitaxel Eluting Balloon
PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sirolimus Eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of target lesion failure (TLF) and target lesion revascularization (TLR)
Measured: at 1 year
Secondary outcomes (26)
Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) (including new MI, TLR or cardiovascular death)
Measured: at 180 days, 1, 2 and 5 years
Rate of MACE
Measured: at 180 days, 1, 2 and 5 years
Rate of new MI (NSTEMI / STEMI)
Measured: at 180 days, 1, 2 and 5 years
Rate of TIA or stroke
Measured: at 180 days, 1, 2 and 5 years
Rate of acute vessel closure
Measured: at 180 days, 1, 2 and 5 years
Rate of stent thrombosis or ISR
Measured: at 180 days, 1, 2 and 5 years
Rate of target vessel revascularization (TVR)
Measured: at 180 days, 1, 2 and 5 years
Rate of target lesion revascularization (TLR)
Measured: at 180 days, 1, 2 and 5 years
Rate of target lesion failure (TLF)
Measured: at 180 days, 1, 2 and 5 years
Rate of ischemia driven TLR
Measured: at 180 days, 1, 2 and 5 years
Rate of all-cause death
Measured: at 180 days, 1, 2 and 5 years
Rate of cardiac death
Measured: at 180 days, 1, 2 and 5 years
Rate of all myocardial infarction and TV-MI
Measured: at 180 days, 1, 2 and 5 years
Rate of rehospitalization for recurrent angina
Measured: at 180 days, 1, 2 and 5 years
Rate of hospitalization for HF
Measured: at 180 days, 1, 2 and 5 years
Rate of rehospitalization for HF, resuscitated cardiac arrest or implantable cardioverter- defibrillator (ICD) implantation
Measured: at 180 days, 1, 2 and 5 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification
Measured: at 180 days, 1, 2 and 5 years
Rate of vascular complications (according to VARC criteria)
Measured: at 180 days, 1, 2 and 5 years
Rate of cardiogenic shock
Measured: at 180 days, 1, 2 and 5 years
Rate of acute renal failure/ contrast-induced nephropathy (CIN)
Measured: at 180 days, 1, 2 and 5 years
Rate of new ventricular arrhythmias
Measured: at 180 days, 1, 2 and 5 years
Rate of major adverse limb events (MALE)
Measured: at 180 days, 1, 2 and 5 years
Rate of new York Heart Association (NYHA) class
Measured: at 180 days, 1, 2 and 5 years
Rate of angina according to Canadian Cardiovascular Society (CCS) Score
Measured: at 180 days, 1, 2 and 5 years
Rate of procedural success (final diameter stenosis < 30% without flow-limiting dissections)
Measured: at 180 days, 1, 2 and 5 years
Rate of periprocedural complications (e.g. coronary perforations, no-reflow)
Measured: at 180 days, 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Principal investigator, Matthias Bossard, Luzerner Kantonsspital
- Investigators
- Florim Cuculi, MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988685
- Sponsor's protocol ID
- 2021-00615
- Acronym
- SIROOP
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2021
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36196027Madanchi 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.
PubMed 36385601Madanchi 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.
PubMed 38414923Madanchi 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.
PubMed 38441987
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04988685
- Acronym / sponsor ID
- SIROOP / 2021-00615
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary Arteriosclerosis, Coronary Artery Calcification, Stable Chronic Angina
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Sirolimus Eluting BalloonThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- Patient is <18 years of age
- Patient unwilling or unable to provide informed consent
- pregnancy and lactation
- Indication for surgical revascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus Eluting BalloonAlso: Paclitaxel Eluting BalloonPTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon | Device | Treatment |
Primary outcome
Rate of target lesion failure (TLF) and target lesion revascularization (TLR)
Time frame: at 1 year
26 secondary outcomes
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
Rate of all myocardial infarction and TV-MI
Time frame: at 180 days, 1, 2 and 5 years
Rate of rehospitalization for recurrent angina
Time frame: at 180 days, 1, 2 and 5 years
Rate of hospitalization for HF
Time frame: at 180 days, 1, 2 and 5 years
Rate of rehospitalization for HF, resuscitated cardiac arrest or implantable cardioverter- defibrillator (ICD) implantation
Time frame: at 180 days, 1, 2 and 5 years
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
Rate of vascular complications (according to VARC criteria)
Time frame: at 180 days, 1, 2 and 5 years
Rate of cardiogenic shock
Time frame: at 180 days, 1, 2 and 5 years
Rate of acute renal failure/ contrast-induced nephropathy (CIN)
Time frame: at 180 days, 1, 2 and 5 years
Rate of new ventricular arrhythmias
Time frame: at 180 days, 1, 2 and 5 years
Rate of major adverse limb events (MALE)
Time frame: at 180 days, 1, 2 and 5 years
Rate of new York Heart Association (NYHA) class
Time frame: at 180 days, 1, 2 and 5 years
Rate of angina according to Canadian Cardiovascular Society (CCS) Score
Time frame: at 180 days, 1, 2 and 5 years
Rate of procedural success (final diameter stenosis < 30% without flow-limiting dissections)
Time frame: at 180 days, 1, 2 and 5 years
Rate of periprocedural complications (e.g. coronary perforations, no-reflow)
Time frame: at 180 days, 1, 2 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publication: PubMed 36196027Cioffi 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.
- Results publication: PubMed 36385601Madanchi 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.
- Results publication: PubMed 38414923Madanchi 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.
- Results publication: PubMed 38441987Madanchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florim Cuculi, MD principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Coronary Artery Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florim Cuculi, MD (+41412052134, florim.cuculi@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of target lesion failure (TLF) and target lesion revascularization (TLR) (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988685, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.