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

S

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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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