Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)

University of Glasgow

Status: Completed

Conditions: Coronary Artery Disease; Angina, Stable; Angina, Unstable

Treatments: Device: OPN strategy; Device: standard strategy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03518645

OPreNBiS

Details and patient eligibility

About

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.

Full 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)

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

OPN strategy

Experimental group

Description:

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.

Treatment:

Device: OPN strategy

standard strategy

Active Comparator group

Description:

Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation.

Treatment:

Device: standard strategy