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

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ClinicalTrials.gov Identifier: NCT02683356
Recruitment Status : Suspended (Company stopped selling BVS)
First Posted : February 17, 2016
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE January 22, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date July 26, 2019
Study Start Date  ICMJE March 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
Minimal in-scaffold lumen area (mm2) as assessed by OCT [ Time Frame: 6 months ]
The lumen area is assessed by OCT
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
Minimal in-scaffold lumen area (mm2) as assessed by OCT [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • Number of adverse events [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    • 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 [ Time Frame: end of procedure ]
    • Minimal in-scaffold lumen area, mm
    • Scaffold expansion, %
    • No of patients with scaffold expansion <80%
    • % lesions with significant malapposition
    • % malapposed struts
  • angiographic endpoints [ Time Frame: end of procedure ]
    • acute lumen gain
    • in-scaffold minimal lumen diameter
    • in-segment minimal lumen diameter
    • in-scaffold % diameter stenosis
    • in-segment % diameter stenosis
  • angiographic endpoints [ Time Frame: 6 months ]
    • 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, %
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
Number of adverse events [ Time Frame: 6 months ]
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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
Official Title  ICMJE Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Occlusion
Intervention  ICMJE
  • Other: OCT-guided PCI
    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
  • Other: Angiography-guided PCI
    Patients assigned to the OCT-guided PCI strategy will only undergo OCT after PCI to determine vessel and lesion dimensions and treatment strategy.
Study Arms  ICMJE
  • Active Comparator: OCT-guided PCI
    OCT before and after Stent implantation
    Intervention: Other: OCT-guided PCI
  • Active Comparator: Angiography-guided PCI
    OCT after Stent implantation
    Intervention: Other: Angiography-guided PCI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683356
Other Study ID Numbers  ICMJE 2016-01-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lorenz Räber, MD PhD Bern University Hospital, Switzerland
Principal Investigator: Stephan Windecker, Prof. MD Bern University Hospital, Switzerland
PRS Account University Hospital Inselspital, Berne
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP