StentsPhase 4OCTOPUSNCT01056744
Optical Coherence Tomography to Evaluate Paclitaxel-Eluting Balloons and Everolimus-Eluting Coronary Stents
A Phase 4 study testing Percutaneous coronary intervention with stent implantation in people with Stents and Neointimal Proliferation, run by University of Jena at 1 site in Germany.
Trial summary
Background: Safety concerns regarding use of drug eluting stent systems (DES) are related mostly to late stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stents, Neointimal Proliferation
- What is being tested?
- Percutaneous coronary intervention with stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Jun 2012
- 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
- Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology
- Age > 18 years, written consent
- Native coronary lesion suitable for stent placement and OCT imaging
Who cannot join
- General exclusion criteria:
- Pregnancy and breast feeding mother
- Co-morbidity with an estimated life expectancy of < 50 % at 1 year
- Scheduled major surgery in the next 6 months
- Not able to give informed written consent or non-compliance
- Participation in other PCI trial
Show all 15Show fewer
- Procedural exclusion criteria:
- Acute coronary syndromes and cardiogenic shock
- Previous subacute or late coronary stent thrombosis
- Known non-responsiveness / allergy to aspirin or thienopyridines
- Known allergy against everolimus or against taxol derivates
- Angiographic exclusion criteria:
- Culprit lesion within the proximal 10 mm of the right or left coronary artery
- Saphenous vein grafts
- Estimated stent length > 30 mm
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Jena, 1st Medical Department, Division of Cardiology
Jena, 07740
About this study
Official title: Endothelial Stent Coverage and Neointimal Proliferation at 6 Months After Implantation of a Coronary Everolimus-Eluting Stent Compared With a Bare Metal Stent Postdilated With a Paclitaxel-Eluting Balloon: A Randomised Study Using Optical Coherence Tomography
Background:
Safety concerns regarding use of drug eluting stent systems (DES) are related mostly to late stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific information about time course and amount of endothelial strut coverage of different DES is required, in order to further refine the concept of antiplatelet therapy after DES implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal proliferation. Very limited OCT data about endothelial coverage of DES are currently available. Aim of this study is a comparative evaluation of XIENCE V® everolimus eluting stent (Abbot Vascular) and of the bare metal stent (BMS) Coroflex® Blue postdilated with the drug-eluting balloon (DEB) SeQuent® Please (paclitaxel-eluting balloon, B. Braun Melsungen AG) in terms of endothelial coverage and neointimal proliferation using OCT.
Read more
Study Design:
A number of 80 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either XIENCE V® or Coroflex® Blue/Sequent® Please. The study is prospectively conducted at a university high-volume PCI center with OCT expertise (Jena, Germany). Angiographic follow-up and OCT imaging with motorized pull-back at 1 mm/s are planned in all patients 6 months after implantation of the study stents. OCT endpoints are: (1) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts, and respectively (2) neointimal proliferation, given as % neointimal volumetric proliferation within the whole stent and also as focal peak % neointimal area proliferation. The study is not powered for clinical endpoints, which are: subacute or late stent thrombosis and need for revascularization of the stent segment. Given the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up to 20%.
- Conditions
- Stents, Neointimal Proliferation
- Being tested
- Percutaneous coronary intervention with stent implantation
- Keywords
- coronary stent, optical coherence tomography, drug-eluting, neointimal proliferation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention with stent implantationDevice
Also called XIENCE® V, Coroflex Blue®, Sequent Please®
Percutaneous coronary intervention with implantation of either:
- a XIENCE® V everolimus eluting coronary stent in one of the following sizes: 3.0 x 18 mm, 3.0 x 28 mm, 2.5 x 18 mm, 2.5 x 28 mm (DES group), or:
- a Coroflex Blue® coronary stent postdilated with a Sequent Please® paclitaxel-eluting balloon in one of the following size combinations (stent / balloon): 3.0 x 16 mm / 3.0 x 20 mm, 3.0 x 25 mm / 3.0 x 30 mm, 2.5 x 16 mm / 2.5 x 20 mm, 2.5 x 25 mm / 2.5 x 30 mm (BMS/DEB group)
| Study group | Role | What they receive |
|---|---|---|
| DES | Active comparator | Implantation of a XIENCE® V everolimus eluting coronary stent (drug-eluting stent, DES) Receives: Device: Percutaneous coronary intervention with stent implantation |
| BMS/DEB | Active comparator | Implantation of a Coroflex Blue® coronary stent (bare metal stent, BMS) postdilated with a Sequent Please® paclitaxel-eluting balloon (drug-eluting balloon, DEB) Receives: Device: Percutaneous coronary intervention with stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial coverage of the stent struts assessed by optical coherence tomography
Measured: 6 months
Secondary outcomes (3)
Neointimal proliferation within the stent assessed by optical coherence tomography
Measured: 6 months
Subacute or late thrombosis of the study stent
Measured: 6 months
Need for revascularization of the vessel segment containing the study stent
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 posted26 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StentsStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG, Abbott Medical Devices, Boston Scientific Corporation
- Responsible party
- Principal investigator, Tudor C. Poerner, University of Jena
- Investigators
- Tudor C Poerner, MD, PhD, Study director, Jena University HospitalHans R Figulla, Professor, Study chair, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056744
- Sponsor's protocol ID
- UKJ-TCP-1
- Acronym
- OCTOPUS
- Status last verified
- Feb 2013
- First submitted
- 25 Jan 2010
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poerner TC, Otto S, Gassdorf J, Nitsche K, Janiak F, Scheller B, Goebel B, Jung C, Figulla HR. Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up. Circ Cardiovasc Interv. 2014 Dec;7(6):760-7. doi: 10.1161/CIRCINTERVENTIONS.113.001146. Epub 2014 Nov 4.
PubMed 25371536Poerner TC, Otto S, Gassdorf J, Janiak F, Danzer C, Ferrari M, Figulla HR. A prospective randomised study using optical coherence tomography to assess endothelial coverage and neointimal proliferation at 6-months after implantation of a coronary everolimus-eluting stent compared with a bare metal stent postdilated with a paclitaxel-eluting balloon (OCTOPUS Trial): rationale, design and methods. EuroIntervention. 2011 May;7 Suppl K:K93-9. doi: 10.4244/EIJV7SKA16.
PubMed 22027737
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Stent Coverage and Neointimal Proliferation at 6 Months After Implantation of a Coronary Everolimus-Eluting Stent Compared With a Bare Metal Stent Postdilated With a Paclitaxel-Eluting Balloon: A Randomised Study Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT01056744
- Acronym / sponsor ID
- OCTOPUS / UKJ-TCP-1
- Conditions
- Stents, Neointimal Proliferation
- Keywords
- coronary stent, optical coherence tomography, drug-eluting, neointimal proliferation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG, Abbott Medical Devices, Boston Scientific Corporation
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Jan 2010 (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.
Background:
Safety concerns regarding use of drug eluting stent systems (DES) are related mostly to late stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific information about time course and amount of endothelial strut coverage of different DES is required, in order to further refine the concept of antiplatelet therapy after DES implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal proliferation. Very limited OCT data about endothelial coverage of DES are currently available. Aim of this study is a comparative evaluation of XIENCE V® everolimus eluting stent (Abbot Vascular) and of the bare metal stent (BMS) Coroflex® Blue postdilated with the drug-eluting balloon (DEB) SeQuent® Please (paclitaxel-eluting balloon, B. Braun Melsungen AG) in terms of endothelial coverage and neointimal proliferation using OCT.
Study Design:
A number of 80 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either XIENCE V® or Coroflex® Blue/Sequent® Please. The study is prospectively conducted at a university high-volume PCI center with OCT expertise (Jena, Germany). Angiographic follow-up and OCT imaging with motorized pull-back at 1 mm/s are planned in all patients 6 months after implantation of the study stents. OCT endpoints are: (1) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts, and respectively (2) neointimal proliferation, given as % neointimal volumetric proliferation within the whole stent and also as focal peak % neointimal area proliferation. The study is not powered for clinical endpoints, which are: subacute or late stent thrombosis and need for revascularization of the stent segment. Given the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up to 20%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DES | Active comparator | Device: Percutaneous coronary intervention with stent implantationImplantation of a XIENCE® V everolimus eluting coronary stent (drug-eluting stent, DES) |
| BMS/DEB | Active comparator | Device: Percutaneous coronary intervention with stent implantationImplantation of a Coroflex Blue® coronary stent (bare metal stent, BMS) postdilated with a Sequent Please® paclitaxel-eluting balloon (drug-eluting balloon, DEB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology
- Age > 18 years, written consent
- Native coronary lesion suitable for stent placement and OCT imaging
Key exclusion criteria (15 listed)
- General exclusion criteria:
- Procedural exclusion criteria:
- Angiographic exclusion criteria:
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 |
|---|---|---|
| Percutaneous coronary intervention with stent implantationAlso: XIENCE® V, Coroflex Blue®, Sequent Please®Percutaneous coronary intervention with implantation of either: - a XIENCE® V everolimus eluting coronary stent in one of the following sizes: 3.0 x 18 mm, 3.0 x 28 mm, 2.5 x 18 mm, 2.5 x 28 mm (DES group), or: - a Coroflex Blue® coronary stent postdilated with a Sequent Please® paclitaxel-eluting balloon in one of the following size combinations (stent / balloon): 3.0 x 16 mm / 3.0 x 20 mm, 3.0 x 25 mm / 3.0 x 30 mm, 2.5 x 16 mm / 2.5 x 20 mm, 2.5 x 25 mm / 2.5 x 30 mm (BMS/DEB group) | Device | BMS/DEB, DES |
Primary outcome
Endothelial coverage of the stent struts assessed by optical coherence tomography
Time frame: 6 months
3 secondary outcomes
Neointimal proliferation within the stent assessed by optical coherence tomography
Time frame: 6 months
Subacute or late thrombosis of the study stent
Time frame: 6 months
Need for revascularization of the vessel segment containing the study stent
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
- Derived from this study: PubMed 25371536Poerner TC, Otto S, Gassdorf J, Nitsche K, Janiak F, Scheller B, Goebel B, Jung C, Figulla HR. Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up. Circ Cardiovasc Interv. 2014 Dec;7(6):760-7. doi: 10.1161/CIRCINTERVENTIONS.113.001146. Epub 2014 Nov 4.
- Derived from this study: PubMed 22027737Poerner TC, Otto S, Gassdorf J, Janiak F, Danzer C, Ferrari M, Figulla HR. A prospective randomised study using optical coherence tomography to assess endothelial coverage and neointimal proliferation at 6-months after implantation of a coronary everolimus-eluting stent compared with a bare metal stent postdilated with a paclitaxel-eluting balloon (OCTOPUS Trial): rationale, design and methods. EuroIntervention. 2011 May;7 Suppl K:K93-9. doi: 10.4244/EIJV7SKA16.
Related trials for Stents
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Recruiting
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Coronary Artery Disease
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
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, PhD study director
Jena University Hospital
Hans R Figulla, Professor study chair
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 Percutaneous coronary intervention with stent implantation in people with Stents and Neointimal Proliferation, 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 15 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: finished, as of the sponsor's last update on 26 Feb 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endothelial coverage of the stent struts assessed by optical coherence tomography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056744, which also lists 2 linked publications.
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 Feb 2013.