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Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPN strategy (study group) | Other | Interventions planned in this arm are as follows:
|
|
| Standard strategy (control group) | Other | Interventions planned in this arm are as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predilatation with OPN NC balloon catheter. | Device | Target lesion will be prepared by predilatation with OPN NC balloon catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section | Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure. | Participants will be followed for the duration of index procedure, an expected average of 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success defined as successful delivery of the scaffold | Participants will be followed for the duration of index procedure, an expected average of 1 hour. | |
| Need for post-dilatation after implantation of the scaffold | Participants will be followed for the duration of index procedure, an expected average of 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with diagnosis of periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin) | Participants will be followed for the duration of hospital stay, an expected average of 5 days. | |
| Number of patients with diagnosis of in-stent restenosis requiring revascularization within 12 months post-procedure |
Inclusion Criteria:
Exclusion Criteria:
Patient characteristics
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| Name | Affiliation | Role |
|---|---|---|
| Florim Cuculi, Prof. dr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luzernen Kantonsspital, Spitalstrasse 16 | Lucerne | 6000 | Switzerland |
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| Predilatation with standard compliant balloon. | Device | Target lesion will be prepared by predilatation with standard balloon catheter (compliant). |
|
| Absorb BVS implantation. | Device | After lesion preparation implantation of BVS Absorb scaffold will be performed. |
|
| Treated segment visualization by OCT. | Procedure | Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT). |
|
| Clinical FU at 12 months. | Other | All patients will be clinically followed for 12 months. |
|
| Scaffold apposition after post-dilatation | Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure. | Participants will be followed for the duration of index procedure, an expected average of 1 hour. |
| Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation, | Participants will be followed for the duration of index procedure, an expected average of 1 hour. |
| 12 month folow up |
| Rate of stent thrombosis according the ARC criteria within 12 months post procedure | 12 month follow up |
| Death or myocardial infarction within 12 months post-procedure | 12 month follow up |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D000789 | Angina, Unstable |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |
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