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 |
|---|---|
| SIS Medical AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS.
Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.
Study design:
Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:
Enrolment:
Randomization of 50 patients
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPN strategy | Experimental | The OPN NC Super High Pressure PTCA Balloon will be used as the study device for lesion preparation for BVS Absorb implantation - OPN strategy of lesion preparation. This balloon has a twin layer balloon construction, which allows a very high pressure resistance of 35 bar. The balloon has a 0.016'' lesion entry profile and is available in sizes between 1.5 and 4.5 mm and lengths of 10, 15 and 20 mm. |
|
| standard strategy | Active Comparator | Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPN strategy | Device | Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons. | Stent apposition will be assessed based on OCT (optical coherence tomography) visualization. | During the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success defined as successful delivery of the scaffold. | The frequency of procedural success will be compared in both study groups. | During the index procedure |
| Need for post-dilatation after initial OCT. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patient characteristics
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Florim Cuculi, MD, PhD | Luzerner Kantonsspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luzerner Kantonsspital | Lucerne | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41663151 | Derived | Ayton SL, Aslam S, Dattani A, Yeo JL, Gulsin GS, Slomka PJ, Dey D, McCann GP, Singh A. Association of epicardial adipose tissue with markers of cardiac remodelling and clinical outcomes in asymptomatic aortic stenosis. Open Heart. 2026 Feb 9;13(1):e003804. doi: 10.1136/openhrt-2025-003804. | |
| 32076567 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000789 | Angina, Unstable |
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| standard strategy | Device | Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation. |
|
The frequency of post-dilatation will be compared in both study groups.
| During the index procedure |
| Scaffold apposition after post-dilatation. | The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups. | During the index procedure |
| Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation. | The frequency of periprocedural complications as dissection, slow-flow, no flow and dissection requiring additional stent implantation will be compared separately in both study group. | During the index procedure |
| Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin). | The frequency of periprocedural myocardial infarction will be compared in both study groups. | During the index procedure |
| In-stent restenosis requiring revascularization within 12 months post-procedure. | The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up. | 12 months after the index procedure |
| Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure. | The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up. | 12 months after the index procedure |
| Death or myocardial infarction within 12 months post procedure. | The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up. | 12 months after the index procedure |
| Cuculi F, Bossard M, Zasada W, Moccetti F, Voskuil M, Wolfrum M, Malinowski KP, Toggweiler S, Kobza R. Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography. Open Heart. 2020 Jan 23;7(1):e001204. doi: 10.1136/openhrt-2019-001204. eCollection 2020. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |