Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
Not provided
Not provided
Not provided
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.
Objectives in detail:
To evaluate procedural success, efficacy, performance and clinical outcomes among various patient cohorts, who undergo PCI using currently available DCBs:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus Eluting Balloon | Device | PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of target lesion failure (TLF) and target lesion revascularization (TLR) | at 1 year |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florim Cuculi, MD | Contact | +41412052134 | florim.cuculi@luks.ch | |
| Matthias Bossard, MD | Contact | +41412051477 | matthias.bossard@luks.ch |
| Name | Affiliation | Role |
|---|---|---|
| Florim Cuculi, MD | Luzerner Kantonsspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luzerner Heart Centre | Recruiting | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36196027 | Result | 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. | |
| 36385601 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 38414923 | Result | 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. |
| 38441987 | Result | 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. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D023903 | Coronary Restenosis |
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D023921 | Coronary Stenosis |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided