In-stent Arterial RestenosisPhase 3NCT01495533
Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter
A Phase 3 study testing uncoated AngioSculpt(R) and Drug coated AngioSculpt(R) in people with In-stent Arterial Restenosis, run by University Hospital, Saarland at 3 sites in 2 countries.
Trial summary
The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Arterial Restenosis
- What is being tested?
- uncoated AngioSculpt(R) and Drug coated AngioSculpt(R)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2011to Jul 2014
- Phase
- Phase 3
- 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
- >18 years of age
- clinical evidence of stable or unstable angina or a positive functional study
- patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)
Who cannot join
- acute myocardial infarction within the past 72 hours
- chronic renal insufficiency with serum creatinine levels >2.0 mg per deciliter%
- known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication
- concomitant medical illness associated with a life-expectancy of less than two years
- stented segment length ≥30 mm, vessel diameter <2.5 mm, diameter stenosis <70%
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Internal Medicine III, UKS
Homburg Saar, 66421
Herzzentrum Leipzig
Leipzig
About this study
Official title: Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study
The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.
Read the detailed description
Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.
- Conditions
- In-stent Arterial Restenosis
- Being tested
- uncoated AngioSculpt(R), Drug coated AngioSculpt(R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uncoated AngioSculpt(R)Device
Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)
Drug coated AngioSculpt(R)Combination product
Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)
| Study group | Role | What they receive |
|---|---|---|
| uncoated AngioSculpt(R) | Active comparator | Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating) Receives: Device: uncoated AngioSculpt(R) |
| drug coated AngioSculpt(R) | Active comparator | Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²) Receives: Combination Product: Drug coated AngioSculpt(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss in-segment
angiographic late lumen loss in-segment assessed by quantitative coronary angiography
Measured: 6 months
Secondary outcomes (2)
Procedural Success
<50% final DS and the absence of in-hospital MACE
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 days
Major adverse cardiovascular events
the occurence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months (before planned control angiography)
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 posted20 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionJul 2014
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 In-stent Arterial RestenosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495533
- Sponsor's protocol ID
- FIM-DCA-01
- Status last verified
- Apr 2023
- First submitted
- 13 Dec 2011
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scheller B, Fontaine T, Mangner N, Hoffmann S, Bonaventura K, Clever YP, Chamie D, Costa R, Gershony G, Kelsch B, Kutschera M, Genereux P, Cremers B, Bohm M, Speck U, Abizaid A. A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial. Catheter Cardiovasc Interv. 2016 Jul;88(1):51-9. doi: 10.1002/ccd.26216. Epub 2015 Sep 2.
PubMed 26331782
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study
- ClinicalTrials.gov ID
- NCT01495533
- Acronym / sponsor ID
- FIM-DCA-01
- Conditions
- In-stent Arterial Restenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Dec 2011 (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 purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.
Detailed description
Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uncoated AngioSculpt(R) | Active comparator | Device: uncoated AngioSculpt(R)Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating) |
| drug coated AngioSculpt(R) | Active comparator | Combination Product: Drug coated AngioSculpt(R)Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age
- clinical evidence of stable or unstable angina or a positive functional study
- patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)
Key exclusion criteria (5 listed)
- acute myocardial infarction within the past 72 hours
- chronic renal insufficiency with serum creatinine levels >2.0 mg per deciliter%
- known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication
- concomitant medical illness associated with a life-expectancy of less than two years
- stented segment length ≥30 mm, vessel diameter <2.5 mm, diameter stenosis <70%
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 |
|---|---|---|
| uncoated AngioSculpt(R)Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating) | Device | uncoated AngioSculpt(R) |
| Drug coated AngioSculpt(R)Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²) | Combination product | drug coated AngioSculpt(R) |
Primary outcome
late lumen loss in-segment
Time frame: 6 months
angiographic late lumen loss in-segment assessed by quantitative coronary angiography
2 secondary outcomes
Procedural Success
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
Major adverse cardiovascular events
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 27 Apr 2023.
- Derived from this study: PubMed 26331782Scheller B, Fontaine T, Mangner N, Hoffmann S, Bonaventura K, Clever YP, Chamie D, Costa R, Gershony G, Kelsch B, Kutschera M, Genereux P, Cremers B, Bohm M, Speck U, Abizaid A. A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial. Catheter Cardiovasc Interv. 2016 Jul;88(1):51-9. doi: 10.1002/ccd.26216. Epub 2015 Sep 2.
Related trials for In-stent Arterial Restenosis
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
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Recruiting
Virtue® SAB in the Treatment of Coronary ISR Trial
Coronary Artery Disease
Recruiting
Prevail Global Study
Coronary Artery Disease
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing uncoated AngioSculpt(R) and Drug coated AngioSculpt(R) in people with In-stent Arterial Restenosis, run by University Hospital, Saarland at 3 sites in 2 countries.
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 5 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
late lumen loss in-segment (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 NCT01495533, 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 Apr 2023.