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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

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).


Condition or disease Intervention/treatment Phase
Coronary Occlusion Other: OCT-guided PCI Other: Angiography-guided PCI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Active Comparator: OCT-guided PCI
OCT before and after Stent implantation
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

Active Comparator: Angiography-guided PCI
OCT after Stent implantation
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.




Primary Outcome Measures :
  1. Minimal in-scaffold lumen area (mm2) as assessed by OCT [ Time Frame: 6 months ]
    The lumen area is assessed by OCT


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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, %

  4. 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

  5. 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

  6. 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, %



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02683356


Locations
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Switzerland
Inselspital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Lorenz Räber, MD PhD Bern University Hospital, Switzerland
Principal Investigator: Stephan Windecker, Prof. MD Bern University Hospital, Switzerland
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02683356    
Other Study ID Numbers: 2016-01-16
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital Inselspital, Berne:
Percutaneous Coronary Intervention
Stents
Additional relevant MeSH terms:
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Coronary Occlusion
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases