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Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds (OPTICO-BVS)

Primary Purpose

Coronary Occlusion

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
OCT-guided PCI
Angiography-guided PCI
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Occlusion focused on measuring Percutaneous Coronary Intervention, Stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age ≥18 years.
  2. Patient provides signed written informed consent before any study-specific procedure.
  3. De novo native coronary artery disease with lesions that have a distal and proximal reference vessel diameter in the range between 2.25mm and 3.8mm.
  4. Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated at baseline with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
  5. Full revascularization of all lesions should be achievable (staged PCI not recommended)
  6. Elective or ad hoc PCI, stable angina and acute coronary syndrome (NSTE-ACS and STEMI).
  7. Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery and evidence of ischemia.

Exclusion Criteria:

  1. Subjects with left main lesion.
  2. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
  3. Subjects with restenosis or stent thrombosis in the target vessel.
  4. Severely calcified lesions requiring rotablation.
  5. Bifurcation with sidebranch >2.5mm or any sidebranch that possibly requires treatment with angulation >70°
  6. Severe angulation (>90°) or excessive tortuosity (>two 45° angles)
  7. Known renal insufficiency (serum creatinine clearance <45ml/min or receiving dialysis).
  8. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
  9. Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
  10. Life expectancy less than 1 year.
  11. Indication for oral anticoagulation
  12. Known allergy against protocol-required medications including ASA, prasugrel, ticagrelor, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated)
  13. History of bleeding diathesis or known coagulopathy.
  14. Planned surgery within the next 6 months

Sites / Locations

  • Inselspital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

OCT-guided PCI

Angiography-guided PCI

Arm Description

OCT before and after Stent implantation

OCT after Stent implantation

Outcomes

Primary Outcome Measures

Minimal in-scaffold lumen area (mm2) as assessed by OCT
The lumen area is assessed by OCT

Secondary Outcome Measures

Number of adverse events
Adverse events are defined as scaffold underexpansions, significant strut malappositions or uncovered struts, expansion asymmetries, any intrascaffold tissue, edge dissections, or restenoses (as assessed by OCT)
OCT imaging endpoints
Scaffold underexpansion, significant strut malapposition or uncovered struts, expansion asymmetry, any intrascaffold tissue, edge dissection, or restenosis. (as assessed by OCT)
Additional OCT imaging endpoints
Significant malapposed scaffold struts, % Malapposed scaffold struts, % Uncovered scaffold struts, % Incomplete scaffold apposition area, mm2 Incomplete scaffold apposition distance, mm Neointimal thickness, µm Neointimal area, mm2 Volume obstruction, %
OCT imaging endpoints
Minimal in-scaffold lumen area, mm Scaffold expansion, % No of patients with scaffold expansion <80% % lesions with significant malapposition % malapposed struts
angiographic endpoints
acute lumen gain in-scaffold minimal lumen diameter in-segment minimal lumen diameter in-scaffold % diameter stenosis in-segment % diameter stenosis
angiographic endpoints
In-scaffold late lumen loss, mm In-segment late lumen loss, mm In-scaffold % diameter stenosis In-segment % diameter stenosis Binary restenosis, % Percent diameter stenosis, %

Full Information

First Posted
January 22, 2016
Last Updated
February 23, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02683356
Brief Title
Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
Acronym
OPTICO-BVS
Official Title
Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Company stopped selling BVS/ No 5 year FUP will be done
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain, restore physiological vasomotion, and avoid late adverse events including restenosis and scaffold thrombosis. Although randomized clinical trials in low risk patients to date suggest non-inferiority in terms of safety and efficacy compared with metallic DES, several reports have raised concerns regarding the scaffold thrombosis highlighting the importance of technical considerations regarding lesion preparation and scaffold expansion. OCT offers the opportunity to plan the procedure and optimize the implantation of BVS. The hypothesis of the present study is that a strategy of OCT-guided PCI using BVS is superior to angiography-guided PCI (e.g. by selecting scaffold dimension on the basis of a pre-procedural OCT and applying corrective measures in case of suboptimal treatment result as indicated by OCT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusion
Keywords
Percutaneous Coronary Intervention, Stents

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCT-guided PCI
Arm Type
Active Comparator
Arm Description
OCT before and after Stent implantation
Arm Title
Angiography-guided PCI
Arm Type
Active Comparator
Arm Description
OCT after Stent implantation
Intervention Type
Other
Intervention Name(s)
OCT-guided PCI
Intervention Description
Patients assigned to the OCT-guided PCI strategy will undergo OCT prior to PCI to determine vessel and lesion dimensions and treatment strategy. OCT will be repeated at the end of the procedure and corrective PCI will aim to optimize the PCI result according to pre-specified criteria in terms of minimal lumen area, scaffold expansion, apposition, residual dissections or intra-scaffold thrombus formation
Intervention Type
Other
Intervention Name(s)
Angiography-guided PCI
Intervention Description
Patients assigned to the OCT-guided PCI strategy will only undergo OCT after PCI to determine vessel and lesion dimensions and treatment strategy.
Primary Outcome Measure Information:
Title
Minimal in-scaffold lumen area (mm2) as assessed by OCT
Description
The lumen area is assessed by OCT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
Adverse events are defined as scaffold underexpansions, significant strut malappositions or uncovered struts, expansion asymmetries, any intrascaffold tissue, edge dissections, or restenoses (as assessed by OCT)
Time Frame
6 months
Title
OCT imaging endpoints
Description
Scaffold underexpansion, significant strut malapposition or uncovered struts, expansion asymmetry, any intrascaffold tissue, edge dissection, or restenosis. (as assessed by OCT)
Time Frame
6 months
Title
Additional OCT imaging endpoints
Description
Significant malapposed scaffold struts, % Malapposed scaffold struts, % Uncovered scaffold struts, % Incomplete scaffold apposition area, mm2 Incomplete scaffold apposition distance, mm Neointimal thickness, µm Neointimal area, mm2 Volume obstruction, %
Time Frame
6 months
Title
OCT imaging endpoints
Description
Minimal in-scaffold lumen area, mm Scaffold expansion, % No of patients with scaffold expansion <80% % lesions with significant malapposition % malapposed struts
Time Frame
end of procedure
Title
angiographic endpoints
Description
acute lumen gain in-scaffold minimal lumen diameter in-segment minimal lumen diameter in-scaffold % diameter stenosis in-segment % diameter stenosis
Time Frame
end of procedure
Title
angiographic endpoints
Description
In-scaffold late lumen loss, mm In-segment late lumen loss, mm In-scaffold % diameter stenosis In-segment % diameter stenosis Binary restenosis, % Percent diameter stenosis, %
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥18 years. Patient provides signed written informed consent before any study-specific procedure. De novo native coronary artery disease with lesions that have a distal and proximal reference vessel diameter in the range between 2.25mm and 3.8mm. Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated at baseline with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel. Full revascularization of all lesions should be achievable (staged PCI not recommended) Elective or ad hoc PCI, stable angina and acute coronary syndrome (NSTE-ACS and STEMI). Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery and evidence of ischemia. Exclusion Criteria: Subjects with left main lesion. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). Subjects with restenosis or stent thrombosis in the target vessel. Severely calcified lesions requiring rotablation. Bifurcation with sidebranch >2.5mm or any sidebranch that possibly requires treatment with angulation >70° Severe angulation (>90°) or excessive tortuosity (>two 45° angles) Known renal insufficiency (serum creatinine clearance <45ml/min or receiving dialysis). Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease. Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy Life expectancy less than 1 year. Indication for oral anticoagulation Known allergy against protocol-required medications including ASA, prasugrel, ticagrelor, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated) History of bleeding diathesis or known coagulopathy. Planned surgery within the next 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenz Räber, MD PhD
Organizational Affiliation
Bern University Hospital, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, Prof. MD
Organizational Affiliation
Bern University Hospital, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds

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