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Completed

NCT Number: NCT03518645

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

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luzerner Kantonsspital

Lucerne, Switzerland

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPN strategy

Device

Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.

standard strategy

Device

Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.

Primary outcomes

  1. Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.

    Time frame: During the index procedure

    Stent apposition will be assessed based on OCT (optical coherence tomography) visualization.

Secondary outcomes

  1. Procedural success defined as successful delivery of the scaffold.

    Time frame: During the index procedure

    The frequency of procedural success will be compared in both study groups.

  2. Need for post-dilatation after initial OCT.

    Time frame: During the index procedure

    The frequency of post-dilatation will be compared in both study groups.

  3. Scaffold apposition after post-dilatation.

    Time frame: During the index procedure

    The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups.

  4. Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.

    Time frame: During the index procedure

    The frequency of periprocedural complications as dissection, slow-flow, no flow and dissection requiring additional stent implantation will be compared separately in both study group.

  5. Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).

    Time frame: During the index procedure

    The frequency of periprocedural myocardial infarction will be compared in both study groups.

  6. In-stent restenosis requiring revascularization within 12 months post-procedure.

    Time frame: 12 months after the index procedure

    The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up.

  7. Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.

    Time frame: 12 months after the index procedure

    The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up.

  8. Death or myocardial infarction within 12 months post procedure.

    Time frame: 12 months after the index procedure

    The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up.

Sponsors and collaborators

Lead sponsor

KCRI

Other

Collaborators

  • SIS Medical AG

Registry information

Official study title

Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study

Acronym: OPreNBiS

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
May 8, 2018
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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