Coronary DiseaseNCT01690572
Drug Eluting Balloon for Prevention of Constrictive Remodeling
A study testing Paclitaxel coated balloon catheter and uncoated balloon catheter "sprinter legend" in people with Coronary Disease and Diabetes Mellitus, run by Prof. Dr. med. Christoph Hehrlein at 1 site in Germany.
Trial summary
Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Diabetes Mellitus
- What is being tested?
- Paclitaxel coated balloon catheter and uncoated balloon catheter "sprinter legend"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Apr 2017
- 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
- at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with a diameter ≤ 2.5 mm
- age > 18 years
- weight > 45 kg
- patient suitable for balloon dilatation and not suitable for elective implantation of a drug eluting stent
- insulin-dependent or non-insulin-dependent diabetes mellitus
- length of lesion ≥ 15 mm
Who cannot join
- Life expectancy < 12 months
- In-Stent restenosis
- planned coronary bypass or heart valve OP
- ST elevation myocardial infarction within the last 72 hours
- cardiogenic shock
- renal impairment or liver dysfunction (creatinine > 2.0 mg/dl, AST/ALT > 3x of normal value
- incompliance
- pregnant or breastfeeding women or women who like to be pregnant
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology and Angiology I, Heart Center,
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
Official title: Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease
Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.
- Conditions
- Coronary Disease, Diabetes Mellitus
- Being tested
- Paclitaxel coated balloon catheter, uncoated balloon catheter "sprinter legend"
- Keywords
- drug eluting balloon, constrictive remodeling
- Medical subject headings
- Coronary Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel coated balloon catheterDevice
Also called IN.PACT Falcon
Dilatation of the target lesion
uncoated balloon catheter "sprinter legend"Device
Also called sprinter legend
Dilatation of the target lesion
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel coated balloon catheter | Active comparator | Paclitaxel coated balloon catheter "IN.PACT Falcon" Receives: Device: Paclitaxel coated balloon catheter |
| uncoated balloon catheter | Active comparator | uncoated balloon catheter "sprinter legend" Receives: Device: uncoated balloon catheter "sprinter legend" |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE-rate
combined end-point: death, myocardial infarction and revascularisation of the target lesion
Measured: 12 months after initial treatment
Secondary outcomes (1)
OCT-measurement
each symptomatic patient will be examined using optical coherence tomography to detect, if the symptoms are caused by a narrowing at the target lesion
Measured: during follow-up, after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2016
- Study completionApr 2017
Why it stopped: recruitment was not sufficient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Christoph Hehrlein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Christoph Hehrlein, Herz-Zentrums Bad Krozingen
- Investigators
- Christoph Hehrlein, Prof. Dr., Principal investigator, Department of Cardiology and Angiology I, Heart Center, Freiburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690572
- Sponsor's protocol ID
- DEBT
- Status last verified
- Apr 2017
- First submitted
- 19 Sep 2012
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease
- ClinicalTrials.gov ID
- NCT01690572
- Acronym / sponsor ID
- DEBT
- Conditions
- Coronary Disease, Diabetes Mellitus
- Keywords
- drug eluting balloon, constrictive remodeling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment was not sufficient.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Prof. Dr. med. Christoph HehrleinUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 21 Sep 2012 (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.
Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel coated balloon catheter | Active comparator | Device: Paclitaxel coated balloon catheterPaclitaxel coated balloon catheter "IN.PACT Falcon" |
| uncoated balloon catheter | Active comparator | Device: uncoated balloon catheter "sprinter legend"uncoated balloon catheter "sprinter legend" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with a diameter ≤ 2.5 mm
- age > 18 years
- weight > 45 kg
- patient suitable for balloon dilatation and not suitable for elective implantation of a drug eluting stent
- insulin-dependent or non-insulin-dependent diabetes mellitus
Key exclusion criteria (8 listed)
- Life expectancy < 12 months
- In-Stent restenosis
- planned coronary bypass or heart valve OP
- ST elevation myocardial infarction within the last 72 hours
- cardiogenic shock
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 |
|---|---|---|
| Paclitaxel coated balloon catheterAlso: IN.PACT FalconDilatation of the target lesion | Device | Paclitaxel coated balloon catheter |
| uncoated balloon catheter "sprinter legend"Also: sprinter legendDilatation of the target lesion | Device | uncoated balloon catheter |
Primary outcome
MACE-rate
Time frame: 12 months after initial treatment
combined end-point: death, myocardial infarction and revascularisation of the target lesion
1 secondary outcome
OCT-measurement
Time frame: during follow-up, after 9 months
Results and safety
The study was stopped early (reason given: recruitment was not sufficient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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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.
Christoph Hehrlein, Prof. Dr. principal investigator
Department of Cardiology and Angiology I, Heart Center, Freiburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel coated balloon catheter and uncoated balloon catheter "sprinter legend" in people with Coronary Disease and Diabetes Mellitus, run by Prof. Dr. med. Christoph Hehrlein 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 6 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: stopped early, as of the sponsor's last update on 28 Apr 2017. 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.
Are results available for this study?
The study was stopped early (reason given: recruitment was not sufficient.). 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?
MACE-rate (time frame: 12 months after initial treatment). 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 28 Apr 2017.