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

SIS Medical

Status: Unknown

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

Treatments: Other: Clinical FU at 12 months.; Device: Predilatation with standard compliant balloon.; Procedure: Treated segment visualization by OCT.; Device: Absorb BVS implantation.; Device: Predilatation with OPN NC balloon catheter.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02468960

OPreNBiS

Details and patient eligibility

About

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.

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 ® 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: 44 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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44 participants in 2 patient groups

OPN strategy (study group)

Other group

Description:

Interventions planned in this arm are as follows: * Predilatation with OPN NC balloon catheter. * Absorb BVS implantation. * Treated segment visualization by OCT. * Clinical FU at 12 months.

Treatment:

Other: Clinical FU at 12 months.

Procedure: Treated segment visualization by OCT.

Device: Absorb BVS implantation.

Device: Predilatation with OPN NC balloon catheter.

Standard strategy (control group)

Other group

Description:

Interventions planned in this arm are as follows: * Predilatation with standard compliant balloon. * Absorb BVS implantation. * Treated segment visualization by OCT. * Clinical FU at 12 months.

Treatment:

Device: Predilatation with standard compliant balloon.

Other: Clinical FU at 12 months.

Procedure: Treated segment visualization by OCT.

Device: Absorb BVS implantation.