Coronary Artery DiseasePhase 4OCTOPUS-3NCT02607241
Comparison of Paclitaxel-Coated Balloons Against Drug-Eluting Bioresorbable Scaffolds for Elective PCI Using OCT
A Phase 4 study testing OCT-guided BRS implantation and FFR-guided DCB-only PCI in people with Coronary Artery Disease, run by University of Jena at 1 site in Germany.
Trial summary
This prospective randomized clinical trial aims to compare two different "metal-free" strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- OCT-guided BRS implantation and FFR-guided DCB-only PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Oct 2018
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written consent
- indication for elective PCI of a de novo coronary stenosis in a native vessel
- coronary multivessel disease with clinically proven indication for repeating coronary angiography at 6-9 months (staged PCI strategy)
Who cannot join
- pregnancy, lactation, women of childbearing age w/o reliable contraception
- life expectance < 50 % at 1 year
- major surgery planned within 6 months
- participation in other clinical trials or impossibility to give written consent
- acute coronary syndrome or cardiogenic shock within the last 4 weeks
- stent thrombosis, defined as "probable" or "definite" by ARC
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- contraindication against dual antiplatelet therapy
- allergy against mTOR-inhibitors or taxol derivates
- target lesion situated in the left main coronary artery, in a bypass graft or a grafted vessel
- reference luminal diameter of the target lesion > 3.75 mm or < 2.0 mm
- lesion length > 30 mm, bifurcation lesion requiring intervention on a major side branch
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Jena, Heart Center, Division of Cardiology
Jena, 07747
About this study
Official title: Comparison of a Paclitaxel-Coated Balloon Without Stent Implantation Against a Drug-Eluting Bioresorbable Scaffold for Treatment of Stable Coronary Artery Disease: A Prospective Randomized Study Using Optical Coherence Tomography
This prospective randomized clinical trial aims to compare two different "metal-free" strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. OCT-guided BRS implantation (bioresorbable scaffold: Absorb™, Abbott Vascular).
Read the detailed description
Background:
Coronary artery disease (CAD) accounts for most deaths in the industrialized countries due to its high prevalence of 6-8%. CAD is mainly treated by percutaneous coronary interventions (PCI), which currently involve in over 90% of cases the implantation of metallic stents, mostly as drug-eluting devices(DES). Despite continuous technological advancement over the last decade, DES are still limited at long-term follow-up by restenosis and also by the risk of thrombosis, occurring in 5-20% and respectively 0.5-1.7% of cases. Therefore, two metal-free strategies are evaluated in order to overcome these intrinsic limitations of DES:
- Bioresorbable scaffolds (BRS) proved comparable safety and efficacy at 1 year compared to best-in-class DES comparators and also showed in small substudies very promising 5-year results with restoration of vasomotricity and positive vessel remodeling. Optical coherence tomography (OCT) is the new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal proliferation. OCT is currently recommended for both guidance of implantation and for assessment of long-term results of BRS.
- Drug-coated balloons (DCB) were mainly employed to treat restenosis in metallic stents, but newer reports advocate their potential to be used as stand-alone treatment of de-novo stenoses without stenting, especially when fractional flow reserve (FFR) measurements are additionally used to assess PCI results.
This clinical trial evaluates the FFR-guided DCB-only (experimental arm: SeQuent Please™, B Braun Melsungen GmBH) PCI against the OCT-guided BRS implantation (comparator arm: Absorb™, Abbott Vascular) for treatment of stable CAD. The trial is designed as a non-inferiority, nationally conducted, multicenter, open-labeled, controlled study using a 1:1 block randomization and am invasive 6-9 month follow-up (f/u) by quantitative coronary angiography (QCA) and OCT.
Beyond the pre-specified endpoints the study mainly looking at suppression of neointimal proliferation, we will also investigate the patterns of healing and neointimal proliferation, the plaque morphology and neoatherosclerosis f/u using OCT at 6-9 months. Clinically, we attempt to record the major adverse cardiovascular events (MACE: acute myocardial infarction, cardiac death, TLR) up to 5 years after the index procedure.
A number of 196 patients scheduled for PCI with a native coronary stenosis suitable for BRS implantation and OCT imaging will be openly 1:1 randomized. This number of patients is considered to be sufficient to prove non-inferiority of DCB-only vs. BRS, using a margin of 0.2 mm with a confidence interval of 0.5 mm for the primary endpoint (diameter NLG).
- Conditions
- Coronary Artery Disease
- Being tested
- OCT-guided BRS implantation, FFR-guided DCB-only PCI
- Keywords
- drug-coated balloon, bioresorbable scaffold, fractional flow reserve, optical coherence tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-guided BRS implantationDevice
Implantation of a BRS using OCT to measure vessel size, choose BRS size and length and assess implantation results and the need of further postdilations
FFR-guided DCB-only PCIDevice
PCI performed under FFR guidance using following algorithm: (1) predilation followed by angiographic assessment of residual stenosis and dissections; (2) evaluate suitability for DCB-only, which is deemed feasible if the FFR > 0.8, residual diameter stenosis < 40% and no flow-limiting dissections are observed; (3) DCB dilation and (4) assessment of final results using FFR and QCA measurements. Provisional stenting is allowed only if the final PCI results are not acceptable (flow-limiting dissection, residual stenosis > 40% or FFR < 0.8).
| Study group | Role | What they receive |
|---|---|---|
| BRS | Active comparator | OCT-guided BRS implantation: implantation of a bioresorbable scaffold (BRS) under OCT guidance.
Note: Absorb™ from Abbott Vascular has been used as BRS until this product became unavailable in April 2017. Currently the recruitment is stopped due to this issue, until the use of another BRS gets final approval. Receives: Device: OCT-guided BRS implantation |
| DCB-only | Experimental | FFR-guided DCB-only PCI: PCI using DCB (SeQuent Please™, B Braun Melsungen GmBH) without stent implantation und FFR guidance Receives: Device: FFR-guided DCB-only PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic NLG
Absolute net luminal diameter gain measured by QCA as minimal luminal diameter at f/u - minimal luminal diameter at baseline within the region of interest
Measured: 6-9 months
Secondary outcomes (3)
Volumetric NLG
Absolute net luminal volumetric gain using three-dimensional OCT-based vessel segment reconstruction at f/u
Measured: 6-9 months
Angiographic and volumetric LLL
Absolute late luminal diameter loss (LLL) using QCA and late luminal volumetric loss by OCT at f/u
Measured: 6-9 months
TLR
% clinically driven target lesion revascularization (TLR) during f/u
Measured: 0-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2018
- Study completionOct 2018
Why it stopped: The product used in the comparator arm (BRS) has become unavailable in April 2017. The recruitment has been stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- KKS Netzwerk
- Responsible party
- Principal investigator, Tudor C. Poerner, MD, University of Jena
- Investigators
- Tudor C Poerner, MD, Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607241
- Sponsor's protocol ID
- UKJ-TCP-3
- Acronym
- OCTOPUS-3
- Status last verified
- Oct 2018
- First submitted
- 15 Nov 2015
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Paclitaxel-Coated Balloon Without Stent Implantation Against a Drug-Eluting Bioresorbable Scaffold for Treatment of Stable Coronary Artery Disease: A Prospective Randomized Study Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02607241
- Acronym / sponsor ID
- OCTOPUS-3 / UKJ-TCP-3
- Conditions
- Coronary Artery Disease
- Keywords
- drug-coated balloon, bioresorbable scaffold, fractional flow reserve, optical coherence tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The product used in the comparator arm (BRS) has become unavailable in April 2017. The recruitment has been stopped.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- KKS Netzwerk
- Study start
- Nov 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 18 Nov 2015 (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.
This prospective randomized clinical trial aims to compare two different "metal-free" strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. OCT-guided BRS implantation (bioresorbable scaffold: Absorb™, Abbott Vascular).
Detailed description
Background:
Coronary artery disease (CAD) accounts for most deaths in the industrialized countries due to its high prevalence of 6-8%. CAD is mainly treated by percutaneous coronary interventions (PCI), which currently involve in over 90% of cases the implantation of metallic stents, mostly as drug-eluting devices(DES). Despite continuous technological advancement over the last decade, DES are still limited at long-term follow-up by restenosis and also by the risk of thrombosis, occurring in 5-20% and respectively 0.5-1.7% of cases. Therefore, two metal-free strategies are evaluated in order to overcome these intrinsic limitations of DES:
- Bioresorbable scaffolds (BRS) proved comparable safety and efficacy at 1 year compared to best-in-class DES comparators and also showed in small substudies very promising 5-year results with restoration of vasomotricity and positive vessel remodeling. Optical coherence tomography (OCT) is the new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal proliferation. OCT is currently recommended for both guidance of implantation and for assessment of long-term results of BRS.
- Drug-coated balloons (DCB) were mainly employed to treat restenosis in metallic stents, but newer reports advocate their potential to be used as stand-alone treatment of de-novo stenoses without stenting, especially when fractional flow reserve (FFR) measurements are additionally used to assess PCI results.
This clinical trial evaluates the FFR-guided DCB-only (experimental arm: SeQuent Please™, B Braun Melsungen GmBH) PCI against the OCT-guided BRS implantation (comparator arm: Absorb™, Abbott Vascular) for treatment of stable CAD. The trial is designed as a non-inferiority, nationally conducted, multicenter, open-labeled, controlled study using a 1:1 block randomization and am invasive 6-9 month follow-up (f/u) by quantitative coronary angiography (QCA) and OCT.
Beyond the pre-specified endpoints the study mainly looking at suppression of neointimal proliferation, we will also investigate the patterns of healing and neointimal proliferation, the plaque morphology and neoatherosclerosis f/u using OCT at 6-9 months. Clinically, we attempt to record the major adverse cardiovascular events (MACE: acute myocardial infarction, cardiac death, TLR) up to 5 years after the index procedure.
A number of 196 patients scheduled for PCI with a native coronary stenosis suitable for BRS implantation and OCT imaging will be openly 1:1 randomized. This number of patients is considered to be sufficient to prove non-inferiority of DCB-only vs. BRS, using a margin of 0.2 mm with a confidence interval of 0.5 mm for the primary endpoint (diameter NLG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRS | Active comparator | Device: OCT-guided BRS implantationOCT-guided BRS implantation: implantation of a bioresorbable scaffold (BRS) under OCT guidance. Note: Absorb™ from Abbott Vascular has been used as BRS until this product became unavailable in April 2017. Currently the recruitment is stopped due to this issue, until the use of another BRS gets final approval. |
| DCB-only | Experimental | Device: FFR-guided DCB-only PCIFFR-guided DCB-only PCI: PCI using DCB (SeQuent Please™, B Braun Melsungen GmBH) without stent implantation und FFR guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written consent
- indication for elective PCI of a de novo coronary stenosis in a native vessel
- coronary multivessel disease with clinically proven indication for repeating coronary angiography at 6-9 months (staged PCI strategy)
Key exclusion criteria (11 listed)
- pregnancy, lactation, women of childbearing age w/o reliable contraception
- life expectance < 50 % at 1 year
- major surgery planned within 6 months
- participation in other clinical trials or impossibility to give written consent
- acute coronary syndrome or cardiogenic shock within the last 4 weeks
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 BRS implantationImplantation of a BRS using OCT to measure vessel size, choose BRS size and length and assess implantation results and the need of further postdilations | Device | BRS |
| FFR-guided DCB-only PCIPCI performed under FFR guidance using following algorithm: (1) predilation followed by angiographic assessment of residual stenosis and dissections; (2) evaluate suitability for DCB-only, which is deemed feasible if the FFR > 0.8, residual diameter stenosis < 40% and no flow-limiting dissections are observed; (3) DCB dilation and (4) assessment of final results using FFR and QCA measurements. Provisional stenting is allowed only if the final PCI results are not acceptable (flow-limiting dissection, residual stenosis > 40% or FFR < 0.8). | Device | DCB-only |
Primary outcome
Angiographic NLG
Time frame: 6-9 months
Absolute net luminal diameter gain measured by QCA as minimal luminal diameter at f/u - minimal luminal diameter at baseline within the region of interest
3 secondary outcomes
Volumetric NLG
Time frame: 6-9 months
Angiographic and volumetric LLL
Time frame: 6-9 months
TLR
Time frame: 0-9 months
Results and safety
The study was stopped early (reason given: The product used in the comparator arm (BRS) has become unavailable in April 2017. The recruitment has been stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
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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.
Tudor C Poerner, MD principal investigator
Jena University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OCT-guided BRS implantation and FFR-guided DCB-only PCI in people with Coronary Artery Disease, run by University of Jena at 1 site in Germany.
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 3 inclusion and 11 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 26 Oct 2018. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The product used in the comparator arm (BRS) has become unavailable in April 2017. The recruitment has been stopped.). 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?
Angiographic NLG (time frame: 6-9 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 26 Oct 2018.