Clinical trial NCT02468960: Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)
Official title: Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Angina
Unstable Angina
Stable Angina
Keywords: Coronary Artery Disease
OPN NC
Angina
Stable
Unstable
Lead sponsor: SIS Medical AG
Sponsor class: INDUSTRY
First posted: 2015-06-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
timeFrame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary outcomes:
measure: Procedural success defined as successful delivery of the scaffold
timeFrame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
measure: Need for post-dilatation after implantation of the scaffold
timeFrame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
measure: Scaffold apposition after post-dilatation
timeFrame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
measure: Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,
timeFrame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Other outcomes:
measure: 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)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
measure: Number of patients with diagnosis of in-stent restenosis requiring revascularization within 12 months post-procedure
timeFrame: 12 month folow up
measure: Rate of stent thrombosis according the ARC criteria within 12 months post procedure
timeFrame: 12 month follow up
measure: Death or myocardial infarction within 12 months post-procedure
timeFrame: 12 month follow up
Locations:
city: Luzern
country: Switzerland
facility: Luzernen Kantonsspital, Spitalstrasse 16
Study officials:
name: Florim Cuculi, Prof. dr
role: PRINCIPAL_INVESTIGATOR
References: