RestenosisSEDUCENCT01065532
SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study
A study testing Sequent Please Paclitaxel eluting balloon and Xience V everolimus eluting stent in people with Restenosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restenosis
- What is being tested?
- Sequent Please Paclitaxel eluting balloon and Xience V everolimus eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- May 2009to Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years
- written informed consent available
- patient eligible for percutaneous coronary intervention
- patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)
- Target reference vessel diameter measured by QCA: 2-4 mm
- Target lesion length measured by QCA < 24 mm
- Target lesion stenosis measured by QCA: > 70%- < 100%
- Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.
Who cannot join
- Left ventricular ejection fraction of < 30%
- Impaired renal function (serum creatinine > 2.0 mg/dl)
- Target lesion located in bifurcation
- Previous and/or planned brachytherapy of target vessel
- Lesion of the left main trunk > 50%, unprotected
- Known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus
Show all 12Show fewer
- Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
- Patients with a life expectancy of less than one year
- Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
- Patient currently enrolled in other investigational device or drug trial
- Patient not able or willing to adhere to follow-up visits
- Patients who previously participated in this study. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing Responses After Treatment of Bare Metal Stent Restenosis With Implantation of an Everolimus-eluting Xience V Stent Versus Use of a Paclitaxel-eluting Balloon: Optical Coherence Tomography Study
Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study.
A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.
Read the detailed description
Background: The optimal treatment of bare metal stent restenosis (implantation of a drug-eluting stent, simple balloon dilatation, CABG) is still not defined. The most used option nowadays is the implantation of a drug-eluting stent (DES). However, this procedure implies application of a double metal layer in the vessel wall, which is linked to delayed healing. Furthermore there might be a higher risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stents. These phenomenon's might give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) were proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising.
Aim: To compare healing processes after treatment of BMS ISR with balloon dilatation using DEB versus implantation of DES.
Methods: 50 patients with BMS restenosis (SVG and bifurcation lesions will be excluded) will be randomized into two treatment groups: SeQuent Please drug-eluting balloon dilatation (group I) versus implantation of an everolimus-eluting Xience V stent (group II). At 9 months, a control angiography with OCT pullback of the treated segment is planned.
- Conditions
- Restenosis
- Being tested
- Sequent Please Paclitaxel eluting balloon, Xience V everolimus eluting stent
- Keywords
- Restenosis, PCI, Drug-eluting stent, Drug-eluting balloon, Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequent Please Paclitaxel eluting balloonDevice
Sequent Please Paclitaxel eluting balloon
Xience V everolimus eluting stentDevice
Xience V everolimus eluting stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | SeQuent Please Drug-eluting balloon Receives: Device: Sequent Please Paclitaxel eluting balloon |
| 2 | Active comparator | Xience V Drug-eluting stent Receives: Device: Xience V everolimus eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent strut coverage and stent strut apposition(assessed with OCT)
Measured: 9 months
Secondary outcomes (1)
Lumen Loss (in-stent) at 9 months In-segment Late Lumen Loss at 9 months Cumulative MACE rate at 9 months Stent thrombosis at all follow-ups Target vessel revascularisation (TVR) at 12 months Device success
Measured: 9 months, 12 months, yearly until 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionNov 2012
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RestenosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Adriaenssens, MD, Principal investigator, UZ LeuvenWalter Desmet, MD, PhD, Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065532
- Sponsor's protocol ID
- EudraCT 2009-011440-20
- Acronym
- SEDUCE
- Status last verified
- Oct 2018
- First submitted
- 8 Feb 2010
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Adriaenssens T, Dens J, Ughi G, Bennett J, Dubois C, Sinnaeve P, Wiyono S, Coosemans M, Belmans A, D'hooge J, Vrolix M, Desmet W. Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial. EuroIntervention. 2014 Aug;10(4):439-48. doi: 10.4244/EIJV10I4A77.
PubMed 25138182
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Responses After Treatment of Bare Metal Stent Restenosis With Implantation of an Everolimus-eluting Xience V Stent Versus Use of a Paclitaxel-eluting Balloon: Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT01065532
- Acronym / sponsor ID
- SEDUCE / EudraCT 2009-011440-20
- Conditions
- Restenosis
- Keywords
- Restenosis, PCI, Drug-eluting stent, Drug-eluting balloon, Optical Coherence Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Feb 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.
Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study.
A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.
Detailed description
Background: The optimal treatment of bare metal stent restenosis (implantation of a drug-eluting stent, simple balloon dilatation, CABG) is still not defined. The most used option nowadays is the implantation of a drug-eluting stent (DES). However, this procedure implies application of a double metal layer in the vessel wall, which is linked to delayed healing. Furthermore there might be a higher risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stents. These phenomenon's might give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) were proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising.
Aim: To compare healing processes after treatment of BMS ISR with balloon dilatation using DEB versus implantation of DES.
Methods: 50 patients with BMS restenosis (SVG and bifurcation lesions will be excluded) will be randomized into two treatment groups: SeQuent Please drug-eluting balloon dilatation (group I) versus implantation of an everolimus-eluting Xience V stent (group II). At 9 months, a control angiography with OCT pullback of the treated segment is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Sequent Please Paclitaxel eluting balloonSeQuent Please Drug-eluting balloon |
| 2 | Active comparator | Device: Xience V everolimus eluting stentXience V Drug-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient older than 18 years
- written informed consent available
- patient eligible for percutaneous coronary intervention
- patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)
- Target reference vessel diameter measured by QCA: 2-4 mm
Key exclusion criteria (12 listed)
- Left ventricular ejection fraction of < 30%
- Impaired renal function (serum creatinine > 2.0 mg/dl)
- Target lesion located in bifurcation
- Previous and/or planned brachytherapy of target vessel
- Lesion of the left main trunk > 50%, unprotected
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 |
|---|---|---|
| Sequent Please Paclitaxel eluting balloonSequent Please Paclitaxel eluting balloon | Device | 1 |
| Xience V everolimus eluting stentXience V everolimus eluting stent | Device | 2 |
Primary outcome
Stent strut coverage and stent strut apposition(assessed with OCT)
Time frame: 9 months
1 secondary outcome
Lumen Loss (in-stent) at 9 months In-segment Late Lumen Loss at 9 months Cumulative MACE rate at 9 months Stent thrombosis at all follow-ups Target vessel revascularisation (TVR) at 12 months Device success
Time frame: 9 months, 12 months, yearly until 5 years
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 27 Jan 2023.
- Derived from this study: PubMed 25138182Adriaenssens T, Dens J, Ughi G, Bennett J, Dubois C, Sinnaeve P, Wiyono S, Coosemans M, Belmans A, D'hooge J, Vrolix M, Desmet W. Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial. EuroIntervention. 2014 Aug;10(4):439-48. doi: 10.4244/EIJV10I4A77.
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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.
Tom Adriaenssens, MD principal investigator
UZ Leuven
Walter Desmet, MD, PhD study director
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequent Please Paclitaxel eluting balloon and Xience V everolimus eluting stent in people with Restenosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 8 inclusion and 12 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 27 Jan 2023. 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 Belgium. 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 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?
Stent strut coverage and stent strut apposition(assessed with OCT) (time frame: 9 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 NCT01065532, which also lists 1 linked publication.
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 27 Jan 2023.