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

Primary Purpose

Coronary Artery Disease, Angina, Unstable, Angina, Stable

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
OPN strategy
standard strategy
Sponsored by
KCRI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, OPN NC, Angina, Stable, Unstable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Luzerner Kantonsspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OPN strategy

standard strategy

Arm 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.

Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation.

Outcomes

Primary Outcome Measures

Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.
Stent apposition will be assessed based on OCT (optical coherence tomography) visualization.

Secondary Outcome Measures

Procedural success defined as successful delivery of the scaffold.
The frequency of procedural success will be compared in both study groups.
Need for post-dilatation after initial OCT.
The frequency of post-dilatation will be compared in both study groups.
Scaffold apposition after post-dilatation.
The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups.
Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.
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.
Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).
The frequency of periprocedural myocardial infarction will be compared in both study groups.
In-stent restenosis requiring revascularization within 12 months post-procedure.
The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up.
Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.
The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up.
Death or myocardial infarction within 12 months post procedure.
The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up.

Full Information

First Posted
April 20, 2018
Last Updated
May 7, 2018
Sponsor
KCRI
Collaborators
SIS Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT03518645
Brief Title
Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds
Acronym
OPreNBiS
Official Title
Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KCRI
Collaborators
SIS Medical AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angina, Unstable, Angina, Stable
Keywords
Coronary Artery Disease, OPN NC, Angina, Stable, Unstable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPN strategy
Arm Type
Experimental
Arm 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.
Arm Title
standard strategy
Arm Type
Active Comparator
Arm Description
Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation.
Intervention Type
Device
Intervention Name(s)
OPN strategy
Intervention Description
Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.
Intervention Type
Device
Intervention Name(s)
standard strategy
Intervention Description
Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.
Primary Outcome Measure Information:
Title
Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.
Description
Stent apposition will be assessed based on OCT (optical coherence tomography) visualization.
Time Frame
During the index procedure
Secondary Outcome Measure Information:
Title
Procedural success defined as successful delivery of the scaffold.
Description
The frequency of procedural success will be compared in both study groups.
Time Frame
During the index procedure
Title
Need for post-dilatation after initial OCT.
Description
The frequency of post-dilatation will be compared in both study groups.
Time Frame
During the index procedure
Title
Scaffold apposition after post-dilatation.
Description
The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups.
Time Frame
During the index procedure
Title
Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.
Description
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.
Time Frame
During the index procedure
Title
Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).
Description
The frequency of periprocedural myocardial infarction will be compared in both study groups.
Time Frame
During the index procedure
Title
In-stent restenosis requiring revascularization within 12 months post-procedure.
Description
The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up.
Time Frame
12 months after the index procedure
Title
Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.
Description
The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up.
Time Frame
12 months after the index procedure
Title
Death or myocardial infarction within 12 months post procedure.
Description
The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up.
Time Frame
12 months after the index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florim Cuculi, MD, PhD
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luzerner Kantonsspital
City
Luzern
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32076567
Citation
Cuculi F, Bossard M, Zasada W, Moccetti F, Voskuil M, Wolfrum M, Malinowski KP, Toggweiler S, Kobza R. Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography. Open Heart. 2020 Jan 23;7(1):e001204. doi: 10.1136/openhrt-2019-001204. eCollection 2020.
Results Reference
derived

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

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