Coronary OcclusionOPTICO-BVSNCT02683356
Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
A study testing OCT-guided PCI and Angiography-guided PCI in people with Coronary Occlusion, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Occlusion
- What is being tested?
- OCT-guided PCI and Angiography-guided PCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Coronary Occlusion
- Being tested
- OCT-guided PCI, Angiography-guided PCI
- Keywords
- Percutaneous Coronary Intervention, Stents
- Medical subject headings
- Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-guided PCIOther
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
Angiography-guided PCIOther
Patients assigned to the OCT-guided PCI strategy will only undergo OCT after PCI to determine vessel and lesion dimensions and treatment strategy.
| Study group | Role | What they receive |
|---|---|---|
| OCT-guided PCI | Active comparator | OCT before and after Stent implantation Receives: Other: OCT-guided PCI |
| Angiography-guided PCI | Active comparator | OCT after Stent implantation Receives: Other: Angiography-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal in-scaffold lumen area (mm2) as assessed by OCT
The lumen area is assessed by OCT
Measured: 6 months
Secondary outcomes (6)
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)
Measured: 6 months
OCT imaging endpoints
Scaffold underexpansion, significant strut malapposition or uncovered struts, expansion asymmetry, any intrascaffold tissue, edge dissection, or restenosis. (as assessed by OCT)
Measured: 6 months
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, %
Measured: 6 months
OCT imaging endpoints
- Minimal in-scaffold lumen area, mm
- Scaffold expansion, %
- No of patients with scaffold expansion <80%
- % lesions with significant malapposition
- % malapposed struts
Measured: end of procedure
angiographic endpoints
- acute lumen gain
- in-scaffold minimal lumen diameter
- in-segment minimal lumen diameter
- in-scaffold % diameter stenosis
- in-segment % diameter stenosis
Measured: end of procedure
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, %
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionMay 2019
Why it stopped: Company stopped selling BVS/ No 5 year FUP will be done
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz Räber, MD PhD, Study chair, Bern University Hospital, SwitzerlandStephan Windecker, Prof. MD, Principal investigator, Bern University Hospital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683356
- Sponsor's protocol ID
- 2016-01-16
- Acronym
- OPTICO-BVS
- Status last verified
- Feb 2022
- First submitted
- 22 Jan 2016
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
- ClinicalTrials.gov ID
- NCT02683356
- Acronym / sponsor ID
- OPTICO-BVS / 2016-01-16
- Conditions
- Coronary Occlusion
- Keywords
- Percutaneous Coronary Intervention, Stents
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company stopped selling BVS/ No 5 year FUP will be done
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-guided PCI | Active comparator | Other: OCT-guided PCIOCT before and after Stent implantation |
| Angiography-guided PCI | Active comparator | Other: Angiography-guided PCIOCT after Stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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°
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT-guided PCIPatients 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 | OCT-guided PCI |
| Angiography-guided PCIPatients assigned to the OCT-guided PCI strategy will only undergo OCT after PCI to determine vessel and lesion dimensions and treatment strategy. | Other | Angiography-guided PCI |
Primary outcome
Minimal in-scaffold lumen area (mm2) as assessed by OCT
Time frame: 6 months
The lumen area is assessed by OCT
6 secondary outcomes
Number of adverse events
Time frame: 6 months
OCT imaging endpoints
Time frame: 6 months
Additional OCT imaging endpoints
Time frame: 6 months
OCT imaging endpoints
Time frame: end of procedure
angiographic endpoints
Time frame: end of procedure
angiographic endpoints
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Company stopped selling BVS/ No 5 year FUP will be done). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenz Räber, MD PhD study chair
Bern University Hospital, Switzerland
Stephan Windecker, Prof. MD principal investigator
Bern University Hospital, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT-guided PCI and Angiography-guided PCI in people with Coronary Occlusion, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company stopped selling BVS/ No 5 year FUP will be done). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal in-scaffold lumen area (mm2) as assessed by OCT (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.