Coronary Artery DiseasePhase 2PEPCAD-CTONCT00670436
The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
A Phase 2 study testing paclitaxel eluting PTCA balloon catheter (SeQuent Please) and paclitaxel eluting Taxus stent (Boston Scientific) in people with Coronary Artery Disease and Chronic Total Occlusion, run by University of Ulm at 2 sites in Germany.
Trial summary
The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Chronic Total Occlusion, Native Coronary Artery
- What is being tested?
- paclitaxel eluting PTCA balloon catheter (SeQuent Please) and paclitaxel eluting Taxus stent (Boston Scientific)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2008to Mar 2014
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic total occlusion
- Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
- occlusion in native coronary artery
- indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
- reference diameter 2.5 mm to 4.0 mm
Who cannot join
- saphenous vein graft
- bifurcation lesion with need to stent main and side branch
- left main occlusion
- de-novo stenosis (no occlusion)
- restenosis
- in-stent restenosis
- contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
- coronary aneurysm at target lesion
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinikum Darmstadt
Darmstadt, 64283
University of Ulm
Ulm, 89081
About this study
Official title: The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.
- Being tested
- paclitaxel eluting PTCA balloon catheter (SeQuent Please), paclitaxel eluting Taxus stent (Boston Scientific)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel eluting PTCA balloon catheter (SeQuent Please)Device
Also called SeQuent Please, paclitaxel eluting balloon
paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery
paclitaxel eluting Taxus stent (Boston Scientific)Device
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| A 1 | Active comparator | paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery Receives: Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please) |
| A2 | Active comparator | historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific) Receives: Device: paclitaxel eluting Taxus stent (Boston Scientific) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late loss
Measured: 6 months
Secondary outcomes (6)
percent diameter stenosis
Measured: 6 months
binary angiographic restenosis rate
Measured: 6 months
late loss index
Measured: 6 months
Target lumen revascularization
Measured: 30 days, 6, 12, 24 months
target vessel revascularization
Measured: 30 days, 6, 12, 24 months
major adverse cardiac events
Measured: 30 days, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionMar 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 Coronary Artery 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Responsible party
- Principal investigator, Jochen Wohrle, University of Ulm
- Investigators
- Jochen Wöhrle, MD; FESC, Principal investigator, University of Ulm, Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670436
- Sponsor's protocol ID
- PEPCAD-CTO V 2.3
- Acronym
- PEPCAD-CTO
- Status last verified
- Jun 2014
- First submitted
- 29 Apr 2008
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wohrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2013 Apr;81(5):793-9. doi: 10.1002/ccd.24409. Epub 2012 Nov 8.
PubMed 22511572
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
- ClinicalTrials.gov ID
- NCT00670436
- Acronym / sponsor ID
- PEPCAD-CTO / PEPCAD-CTO V 2.3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 May 2008 (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 aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A 1 | Active comparator | Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery |
| A2 | Active comparator | Device: paclitaxel eluting Taxus stent (Boston Scientific)historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic total occlusion
- Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
- occlusion in native coronary artery
- indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
- reference diameter 2.5 mm to 4.0 mm
Key exclusion criteria (8 listed)
- saphenous vein graft
- bifurcation lesion with need to stent main and side branch
- left main occlusion
- de-novo stenosis (no occlusion)
- restenosis
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 eluting PTCA balloon catheter (SeQuent Please)Also: SeQuent Please, paclitaxel eluting balloonpaclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery | Device | A 1 |
| paclitaxel eluting Taxus stent (Boston Scientific)paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries | Device | A2 |
Primary outcome
Late loss
Time frame: 6 months
6 secondary outcomes
percent diameter stenosis
Time frame: 6 months
binary angiographic restenosis rate
Time frame: 6 months
late loss index
Time frame: 6 months
Target lumen revascularization
Time frame: 30 days, 6, 12, 24 months
target vessel revascularization
Time frame: 30 days, 6, 12, 24 months
major adverse cardiac events
Time frame: 30 days, 6, 12, 24 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 10 Jun 2014.
- Background: PubMed 22511572Wohrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2013 Apr;81(5):793-9. doi: 10.1002/ccd.24409. Epub 2012 Nov 8.
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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.
Jochen Wöhrle, MD; FESC principal investigator
University of Ulm, Ulm, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel eluting PTCA balloon catheter (SeQuent Please) and paclitaxel eluting Taxus stent (Boston Scientific) in people with Coronary Artery Disease and Chronic Total Occlusion, run by University of Ulm at 2 sites 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 5 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: finished, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 loss (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 NCT00670436, 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 10 Jun 2014.