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

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ClinicalTrials.gov Identifier: NCT02468960
Recruitment Status : Unknown
Verified April 2017 by SIS Medical AG.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2015
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
SIS Medical AG

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Angina Unstable Angina Stable Angina Device: Predilatation with OPN NC balloon catheter. Device: Predilatation with standard compliant balloon. Device: Absorb BVS implantation. Procedure: Treated segment visualization by OCT. Other: Clinical FU at 12 months. 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 ® 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 : 44 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
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
OPN strategy (study group)

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.
Device: Predilatation with OPN NC balloon catheter.
Target lesion will be prepared by predilatation with OPN NC balloon catheter.

Device: Absorb BVS implantation.
After lesion preparation implantation of BVS Absorb scaffold will be performed.

Procedure: Treated segment visualization by OCT.
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).

Other: Clinical FU at 12 months.
All patients will be clinically followed for 12 months.

Standard strategy (control group)

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.
Device: Predilatation with standard compliant balloon.
Target lesion will be prepared by predilatation with standard balloon catheter (compliant).

Device: Absorb BVS implantation.
After lesion preparation implantation of BVS Absorb scaffold will be performed.

Procedure: Treated segment visualization by OCT.
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).

Other: Clinical FU at 12 months.
All patients will be clinically followed for 12 months.




Primary Outcome Measures :
  1. Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section [ Time Frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour. ]
    Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.


Secondary Outcome Measures :
  1. Procedural success defined as successful delivery of the scaffold [ Time Frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour. ]
  2. Need for post-dilatation after implantation of the scaffold [ Time Frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour. ]
  3. Scaffold apposition after post-dilatation [ Time Frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour. ]
    Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.

  4. Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation, [ Time Frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour. ]

Other Outcome Measures:
  1. Number of patients with diagnosis of periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days. ]
  2. Number of patients with diagnosis of in-stent restenosis requiring revascularization within 12 months post-procedure [ Time Frame: 12 month folow up ]
  3. Rate of stent thrombosis according the ARC criteria within 12 months post procedure [ Time Frame: 12 month follow up ]
  4. Death or myocardial infarction within 12 months post-procedure [ Time Frame: 12 month 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): NCT02468960


Locations
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Switzerland
Luzernen Kantonsspital, Spitalstrasse 16
Luzern, Switzerland, 6000
Sponsors and Collaborators
SIS Medical AG
Investigators
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Principal Investigator: Florim Cuculi, Prof. dr

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Responsible Party: SIS Medical AG
ClinicalTrials.gov Identifier: NCT02468960     History of Changes
Other Study ID Numbers: OPreNBiS
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: April 2017
Keywords provided by SIS Medical AG:
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, Stable
Angina, Unstable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms