Angina, Coronary Artery Disease, Stable Angina, Unstable Angina
Conditions
Keywords
Coronary Artery Disease, OPN NC, Angina, Stable, Unstable
Brief summary
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.
Detailed description
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: * OPN strategy (study group): pre-dilatation with OPN NC ® Super High Pressure PTCA (Percutaneous Transluminal Coronary Angioplasty) balloons * standard strategy (control group): pre-dilatation with a standard (compliant) balloon Enrolment: Randomization of 50 patients * 25 in the OPN strategy (study group) * 25 in the standard strategy (control group)
Interventions
DEVICEPredilatation with OPN NC balloon catheter.
Target lesion will be prepared by predilatation with OPN NC balloon catheter.
DEVICEPredilatation with standard compliant balloon.
Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
DEVICEAbsorb BVS implantation.
After lesion preparation implantation of BVS Absorb scaffold will be performed.
PROCEDURETreated segment visualization by OCT.
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
OTHERClinical FU at 12 months.
All patients will be clinically followed for 12 months.
Sponsors
SIS Medical AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years. * Able and willing to give informed consent. * Willing to comply with specified follow-up evaluations. * Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction. * De novo lesion. * Angiographic diameter stenosis \> 70 % and/or fractional flow reserve \<0.80. * Vessel diameter between 2.5 and 4.0 mm. * One- or two vessel disease (defined as diameter stenosis \> 70 % in vessels with a diameter \> 2.5 mm). * Up to two lesions in one or two vessels can be treated
Exclusion criteria
* Patient characteristics * Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure. * Patient with contraindication for 12 months of dual antiplatelet therapy. * ST-elevation myocardial infarction. * Any contraindication to the implantation of BVS. Lesion characteristics * Visible thrombus in coronary angiography * Chronic total occlusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section | Participants will be followed for the duration of index procedure, an expected average of 1 hour. | Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| Scaffold apposition after post-dilatation | Participants will be followed for the duration of index procedure, an expected average of 1 hour. | Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure. |
| 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. | — |
Other
| Measure | Time frame |
|---|---|
| Number of patients with diagnosis of in-stent restenosis requiring revascularization within 12 months post-procedure | 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 |
| 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. |
Countries
Switzerland
Outcome results
None listed