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

U

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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