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

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ClinicalTrials.gov Identifier: NCT03518645
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
SIS Medical AG
Information provided by (Responsible Party):
Wojciech Zasada, KCRI

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Angina, Unstable Angina, Stable Device: OPN strategy Device: standard strategy Not Applicable

Detailed 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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 29, 2018

Arm Intervention/treatment
Experimental: OPN strategy
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.
Device: OPN strategy
Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.

Active Comparator: standard strategy
Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation.
Device: standard strategy
Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518645


Locations
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Switzerland
Luzerner Kantonsspital
Luzern, Switzerland
Sponsors and Collaborators
KCRI
SIS Medical AG
Investigators
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Principal Investigator: Florim Cuculi, MD, PhD Luzerner Kantonsspital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wojciech Zasada, MD, PhD, KCRI
ClinicalTrials.gov Identifier: NCT03518645    
Other Study ID Numbers: OPreNBiS
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by Wojciech Zasada, KCRI:
Coronary Artery Disease
OPN NC
Angina
Stable
Unstable
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Unstable
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms