Clinical trial NCT03518645: Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds
Official title: Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Angina, Unstable
Angina, Stable
Keywords: Coronary Artery Disease
OPN NC
Angina
Stable
Unstable
Lead sponsor: KCRI
Sponsor class: OTHER
Collaborators: name: SIS Medical AG
First posted: 2018-05-08
Enrollment: 43
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.

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 (non-compliant) 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: Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.
timeFrame: During the index procedure
Secondary outcomes:
measure: Procedural success defined as successful delivery of the scaffold.
timeFrame: During the index procedure
measure: Need for post-dilatation after initial OCT.
timeFrame: During the index procedure
measure: Scaffold apposition after post-dilatation.
timeFrame: During the index procedure
measure: Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.
timeFrame: During the index procedure
measure: Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).
timeFrame: During the index procedure
measure: In-stent restenosis requiring revascularization within 12 months post-procedure.
timeFrame: 12 months after the index procedure
measure: Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.
timeFrame: 12 months after the index procedure
measure: Death or myocardial infarction within 12 months post procedure.
timeFrame: 12 months after the index procedure
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Luzerner Kantonsspital
name: Florim Cuculi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.