In-stent RestenosisNCT01127958
DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent.
A study testing PCI with a drug-eluting balloon and PCI with a drug-eluting stent in people with In-stent Restenosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 8 sites in Netherlands.
Trial summary
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Restenosis
- What is being tested?
- PCI with a drug-eluting balloon and PCI with a drug-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 8 sitesNetherlands
- Study dates
- May 2010to Jun 2020
- 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
- Restenosis of the initially stented main vessel, including ostial, left main and bifurcation lesions as well as venous or arterial grafts
- Restenosis of any type of stent; all drug-eluting stents or bare metal stents
- Restenosis must be present > 50% in-stent and < 5 mm out of the stent
- A reference diameter of ≥ 2.0 to 4.0 millimeters by visual estimation
- Amendable to PCI treatment with either the SeQuent ® Please DEB or the Xience™ Prime DES
- Amendable to dual antiplatelet treatment for the duration of 1 year
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- Patients must be ≥ 18 years of age
- Patients must be able to understand the aim of the study, including risks, benefits and treatment alternatives
- Patients must agree to undergo a follow-up angiogram at 6 months (± 1 month)
- Patients must agree to undergo a clinical follow-up at 30 days, 6 months, 1, 2, 3, 4, and 5 years
Who cannot join
- The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure is considered an exclusion criterion for this study
- Patients have to meet the inclusion criteria;
- Life expectancy less than one year
- Severe renal insufficiency (glomerular filtration rate <30mL/min), with exception of of patients with renal dialysis
- STEMI
- Restenosis in a biodegradable stent
- Restenosis in a non CE marked stent
- Requirement for PCI in the same vessel or expected in the next 6 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
Academisch Medisch Centrum
Amsterdam, 1105AZ
OLVG
Amsterdam
VUmc
Amsterdam
Tergooi Ziekenhuizen
Blaricum
Amphia Ziekenhuis
Breda
Albert Schweitzer ziekenhuis
Dordrecht, 3300AK
UMC St Radboud
Nijmegen, 6500HB
Isala klinieken
Zwolle
About this study
Official title: DARE-Trial: Drug Eluting bAlloon for In-stent REstenosis. Multi-center, Randomized Trial to Study the Effect of the SeQuent Please Drug-eluting Balloon Versus the Xience Prime Drug-eluting Stent for the Treatment of In-stent Restenosis.
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.
Read the detailed description
Background of the study:
Coronary in-stent restenosis is commonly treated by using a drug eluting stent (DES). There are, however, some concerns about the safety of drug eluting stents, in particular with respect to delayed healing, chronic inflammatory reaction, and late or very late stent thrombosis. It is unknown whether the current treatment with another layer of stents may add to the risk of stent thrombosis or reoccurrence of restenosis. Therefore, the relatively new drug-eluting balloons may provide an alternative for treatment of in-stent restenosis, avoiding a double stent layer. The expected advantages of such drug-eluting balloons over stents are the ease of access of the lesion, the absence of a multiple stent layer, and the shorter necessity of the use of dual antiplatelet therapy. Several studies have demonstrated safety and efficacy of the Sequent Please drug-eluting balloon (DEB). Whether the drug eluting balloon is as effective as a drug eluting stent in preventing re-restenosis is not known.
Study design:
The study is designed as an multi-center, randomized, prospective two-arm trial with either PCI with a drug eluting balloon or a drug eluting stent for in-stent restenosis. Blinded evaluation of endpoints by independent core laboratory.
Study population:
The study population consists of 270 patients ( ≥ 18 years of age) with indication for PCI for in-stent restenosis of whom 135 are randomised to a drug eluting balloon and 135 are randomised to a drug eluting stent. Individuals have signed an informed consent for study measurements.
Intervention:
PCI with a drug-eluting stent, or PCI with a drug-eluting balloon.
- Conditions
- In-stent Restenosis
- Being tested
- PCI with a drug-eluting balloon, PCI with a drug-eluting stent
- Keywords
- In-stent restenosis, Minimal lumen diameter, Drug eluting balloon, Drug eluting stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI with a drug-eluting balloonDevice
PCI with a drug-eluting balloon for in-stent restenosis
PCI with a drug-eluting stentDevice
PCI with a drug-eluting stent for in-stent restenosis
| Study group | Role | What they receive |
|---|---|---|
| SeQuent Please | Active comparator | PCI with drug-eluting balloon Receives: Device: PCI with a drug-eluting balloon |
| Xience Prime | Active comparator | PCI with a drug-eluting stent Receives: Device: PCI with a drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is the minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI
The primary objective of this study is to determine whether PCI with the SeQuent ® Please DEB versus PCI with the Xience™ Prime DES for the treatment of patients with in-stent restenosis is non-inferior with respect to minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at six months.
Measured: 6 month's after PCI
Secondary outcomes (3)
In-stent and in-segment percent Diameter Stenosis
Measured: 6 months
In-stent and in-segment Angiographic binary restenosis
Measured: 6 months
Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm
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 posted21 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent RestenosisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Medical B.V.
- Responsible party
- Principal investigator, J. Baan, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jan Baan, Dr, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127958
- Sponsor's protocol ID
- NL3148701810
- Status last verified
- Feb 2017
- First submitted
- 18 May 2010
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DARE-Trial: Drug Eluting bAlloon for In-stent REstenosis. Multi-center, Randomized Trial to Study the Effect of the SeQuent Please Drug-eluting Balloon Versus the Xience Prime Drug-eluting Stent for the Treatment of In-stent Restenosis.
- ClinicalTrials.gov ID
- NCT01127958
- Acronym / sponsor ID
- NL3148701810
- Conditions
- In-stent Restenosis
- Keywords
- In-stent restenosis, Minimal lumen diameter, Drug eluting balloon, Drug eluting stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- B. Braun Medical B.V.
- Study start
- May 2010
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 21 May 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.
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.
Detailed description
Background of the study:
Coronary in-stent restenosis is commonly treated by using a drug eluting stent (DES). There are, however, some concerns about the safety of drug eluting stents, in particular with respect to delayed healing, chronic inflammatory reaction, and late or very late stent thrombosis. It is unknown whether the current treatment with another layer of stents may add to the risk of stent thrombosis or reoccurrence of restenosis. Therefore, the relatively new drug-eluting balloons may provide an alternative for treatment of in-stent restenosis, avoiding a double stent layer. The expected advantages of such drug-eluting balloons over stents are the ease of access of the lesion, the absence of a multiple stent layer, and the shorter necessity of the use of dual antiplatelet therapy. Several studies have demonstrated safety and efficacy of the Sequent Please drug-eluting balloon (DEB). Whether the drug eluting balloon is as effective as a drug eluting stent in preventing re-restenosis is not known.
Study design:
The study is designed as an multi-center, randomized, prospective two-arm trial with either PCI with a drug eluting balloon or a drug eluting stent for in-stent restenosis. Blinded evaluation of endpoints by independent core laboratory.
Study population:
The study population consists of 270 patients ( ≥ 18 years of age) with indication for PCI for in-stent restenosis of whom 135 are randomised to a drug eluting balloon and 135 are randomised to a drug eluting stent. Individuals have signed an informed consent for study measurements.
Intervention:
PCI with a drug-eluting stent, or PCI with a drug-eluting balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SeQuent Please | Active comparator | Device: PCI with a drug-eluting balloonPCI with drug-eluting balloon |
| Xience Prime | Active comparator | Device: PCI with a drug-eluting stentPCI with a 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 (10 listed)
- Restenosis of the initially stented main vessel, including ostial, left main and bifurcation lesions as well as venous or arterial grafts
- Restenosis of any type of stent; all drug-eluting stents or bare metal stents
- Restenosis must be present > 50% in-stent and < 5 mm out of the stent
- A reference diameter of ≥ 2.0 to 4.0 millimeters by visual estimation
- Amendable to PCI treatment with either the SeQuent ® Please DEB or the Xience™ Prime DES
Key exclusion criteria (8 listed)
- The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure is considered an exclusion criterion for this study
- Patients have to meet the inclusion criteria;
- Life expectancy less than one year
- Severe renal insufficiency (glomerular filtration rate <30mL/min), with exception of of patients with renal dialysis
- STEMI
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 |
|---|---|---|
| PCI with a drug-eluting balloonPCI with a drug-eluting balloon for in-stent restenosis | Device | SeQuent Please |
| PCI with a drug-eluting stentPCI with a drug-eluting stent for in-stent restenosis | Device | Xience Prime |
Primary outcome
The primary objective of this study is the minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI
Time frame: 6 month's after PCI
The primary objective of this study is to determine whether PCI with the SeQuent ® Please DEB versus PCI with the Xience™ Prime DES for the treatment of patients with in-stent restenosis is non-inferior with respect to minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at six months.
3 secondary outcomes
In-stent and in-segment percent Diameter Stenosis
Time frame: 6 months
In-stent and in-segment Angiographic binary restenosis
Time frame: 6 months
Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
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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.
Jan Baan, Dr principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI with a drug-eluting balloon and PCI with a drug-eluting stent in people with In-stent Restenosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 8 sites in Netherlands.
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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. 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?
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?
The primary objective of this study is the minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI (time frame: 6 month's after PCI). 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 17 Feb 2017.