AngioplastyPhase 4PEPCAD-BIFNCT01180517
The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations
A Phase 4 study testing Percutaneous coronary intervention (PCI) and PCI in people with Angioplasty, run by Ralf Degenhardt, PhD at 2 sites in Germany.
Trial summary
The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) of Medina 0,0,1 coronary bifurcation lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty
- What is being tested?
- Percutaneous coronary intervention (PCI) and PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2010to Feb 2016
- Phase
- Phase 4
- 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
- De-novo Medina type 0,0,1 bifurcational native coronary artery lesion (reference diameter:>2.0 mm <3.5 mm, length of stenosis: ≤ 10 mm), the diameter of the side branch shall be smaller or equal to the diameter of the distal end vessel
Who cannot join
- Reference side branch diameter > 3.5 mm
- Evidence of extensive thrombosis within target vessel
- Patients with another coronary stent implanted previously into the target branch or bifurcation ≤ 15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD- BIF
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Herzzentrum Dresden
Dresden, 01307
Klinikum Ernst von Bergmann
Potsdam, 14467
About this study
Official title: The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations
The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.
- Conditions
- Angioplasty
- Being tested
- Percutaneous coronary intervention (PCI), PCI
- Keywords
- Angioplasty Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Procedure or surgery
balloon angioplasty
PCIProcedure or surgery
balloon angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Balloon | Active comparator | Not described Receives: Procedure: Percutaneous coronary intervention (PCI) |
| Plain Old Balloon Angioplasty (POBA) | Active comparator | Not described Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late lumen loss in the side branch at 9 months
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2014
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioplastyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ralf Degenhardt, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Responsible party
- Sponsor-investigator, Ralf Degenhardt, PhD, Heart Centre Rotenburg
- Investigators
- F. X. Kleber, MD, Principal investigator, Klinikum Ernst von Bergmann Potsdam, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180517
- Sponsor's protocol ID
- AAG-G-H-1003
- Acronym
- PEPCAD-BIF
- Status last verified
- Feb 2016
- First submitted
- 9 Aug 2010
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations
- ClinicalTrials.gov ID
- NCT01180517
- Acronym / sponsor ID
- PEPCAD-BIF / AAG-G-H-1003
- Conditions
- Angioplasty
- Keywords
- Angioplasty Balloon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ralf Degenhardt, PhDUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Study start
- Nov 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 Aug 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 intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Eluting Balloon | Active comparator | Procedure: Percutaneous coronary intervention (PCI) |
| Plain Old Balloon Angioplasty (POBA) | Active comparator | Procedure: PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- De-novo Medina type 0,0,1 bifurcational native coronary artery lesion (reference diameter:>2.0 mm <3.5 mm, length of stenosis: ≤ 10 mm), the diameter of the side branch shall be smaller or equal to the diameter of the distal end vessel
Key exclusion criteria (3 listed)
- Reference side branch diameter > 3.5 mm
- Evidence of extensive thrombosis within target vessel
- Patients with another coronary stent implanted previously into the target branch or bifurcation ≤ 15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD- BIF
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 |
|---|---|---|
| Percutaneous coronary intervention (PCI)balloon angioplasty | Procedure or surgery | Drug Eluting Balloon |
| PCIballoon angioplasty | Procedure or surgery | Plain Old Balloon Angioplasty (POBA) |
Primary outcome
In-segment late lumen loss in the side branch at 9 months
Time frame: 9 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 19 Feb 2016.
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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.
F. X. Kleber, MD principal investigator
Klinikum Ernst von Bergmann Potsdam, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous coronary intervention (PCI) and PCI in people with Angioplasty, run by Ralf Degenhardt, PhD 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 1 inclusion and 3 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 19 Feb 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
In-segment late lumen loss in the side branch at 9 months (time frame: 9 months). 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 19 Feb 2016.