In-stent Coronary Artery RestenosisPEPPERNCT00961181
Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis
A study testing Paclitaxel Releasing Balloon in people with In-stent Coronary Artery Restenosis, run by Biotronik AG at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Coronary Artery Restenosis
- What is being tested?
- Paclitaxel Releasing Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient >/= 18 years
- Written patient informed consent available
- Patients with stable, unstable or documented silent angina pectoris
- Patient eligible for percutaneous coronary intervention
- Patient acceptable candidate for coronary artery bypass surgery
- Patients with a single restenotic lesion in a previously stented area of a coronary artery (irrelevant whether BMS or DES related)
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- Target reference vessel diameter (visual estimation): 2 - 4 mm
- Target lesion length (visual estimation): 8 - 28 mm
- Target lesion stenosis (visual estimation): >/= 50% - < 100%
Who cannot join
- Left ventricular ejection fraction of < 30%
- Visible thrombus in the target vessel visualized by angiography
- Myocardial infarction (STEMI/NSTEMI) within 72 hours of the intended treatment. Determination of CKMB and/or troponin T or I is required.
- Notes:
- Laboratory assessments to be done within 24 hours prior to intervention. Patients with CKMB and/or troponin T or I > 2 fold the upper limit of normal must not be included in the trial.
- Patients with planned major surgery within 3 months after planned coronary intervention and/or risk of either acetylsalicylic acid of clopidogrel cessation
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- Lesion length longer than length of available treatment balloon
- Impaired renal function (serum creatinine > 2.0mg/dl or 177 micro mol/l, determined within 72 hours prior to intervention)
- Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
- Totally occluded coronary artery (Mehran classification IV and TIMI flow 0)
- Target lesion located in vessel bifurcation
- Previous and/or planned brachytherapy of target vessel
- Target lesion located in left main coronary artery
- Stroke or TIA < 6 months prior to procedure
- Patient with signs of a cardiogenic shock
- Patient under ongoing systemic immunosuppressive therapy with paclitaxel or agents of the -limus group (i.e. sirolimus, tacrolimus, everolimus)
- Surgeries of any kind within 30 days prior to screening
- Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
- Known allergies to anti-platelet-, anticoagulation therapy, contrast media or paclitaxel
- Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required for females of child-bearing potential)
- Patient with a life expectancy of less than one year
- Patient currently enrolled in other investigational device or drug trial
- Patient with known incompliance to medical (antiplatelet, anticoagulation) therapy
- Patient not able or willing to adhere to follow-up visits including follow-up angiography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis A Prospective, Multi-centre, Non-randomized Clinical Trial With Follow-up Investigations at 1, 6 and 12 Months
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.
Read the detailed description
All patients are treated with the paclitaxel releasing balloon Pantera Lux. The indication is in-stent restenosis in either bare metal stent (BMS) or drug eluting stent (DES).
Clinical follow up visits at 1, 6 and 12 months. Angiographic follow up visit at 6 months.
- Conditions
- In-stent Coronary Artery Restenosis
- Being tested
- Paclitaxel Releasing Balloon
- Keywords
- paclitaxel, in-stent restenosis, BMS-ISR, DES-ISR, drug eluting balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Releasing BalloonDevice
Also called Pantera Lux
Percutaneous coronary intervention with paclitaxel releasing balloon
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel Releasing Balloon | Experimental | Percutaneous coronary intervention with paclitaxel releasing balloon Receives: Device: Paclitaxel Releasing Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent Late Lumen Loss
In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.
Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
Measured: 6 months
Secondary outcomes (9)
In-segment Late Lumen Loss
In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.
Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
Measured: 6 months
Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)
All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.
Major Adverse Cardiac Events = MACE Myocardial Infarction = MI Target Lesion Revascularization = TLR Target Vessel Revascularization = TVR
Measured: 6 months
Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)
All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.
Measured: 12 months
In-stent Diameter Stenosis (%DS)
In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
Measured: 6 months
In-segment Diameter Stenosis (%DS)
In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
Measured: 6 months
Binary In-stent Restenosis
In-sent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.
Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
Measured: 6 months
Binary In-segment Restenosis
In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.
Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
Measured: 6 months
Technical Success
Technical success is defined as successful vascular access, completion of the endovascular procedure and immediate morphological success with < 30% residual diameter stenosis assessed by quantitative coronary angiography (QCA).
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
Measured: directly after intervention (after finalized treatment)
Device Success
Device success defined as exact deployment of the device as documented by two different projections assessed by quantitative coronary angiography (QCA).
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
Measured: directly after intervention (after finalized treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for In-stent Coronary Artery 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Hehrlein, MD, Principal investigator, University Medical Center, Freiburg i.Br., Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961181
- Sponsor's protocol ID
- C0902
- Acronym
- PEPPER
- Status last verified
- May 2013
- First submitted
- 13 Aug 2009
- Last updated
- 6 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hehrlein C, Dietz U, Kubica J, Jorgensen E, Hoffmann E, Naber C, Lesiak M, Schneider H, Wiemer M, Tolg R, Richardt G. Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial. Cardiovasc Revasc Med. 2012 Sep-Oct;13(5):260-4. doi: 10.1016/j.carrev.2012.06.002. Epub 2012 Aug 4.
PubMed 22867706
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis A Prospective, Multi-centre, Non-randomized Clinical Trial With Follow-up Investigations at 1, 6 and 12 Months
- ClinicalTrials.gov ID
- NCT00961181
- Acronym / sponsor ID
- PEPPER / C0902
- Conditions
- In-stent Coronary Artery Restenosis
- Keywords
- paclitaxel, in-stent restenosis, BMS-ISR, DES-ISR, drug eluting balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Posted 3 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.
Detailed description
All patients are treated with the paclitaxel releasing balloon Pantera Lux. The indication is in-stent restenosis in either bare metal stent (BMS) or drug eluting stent (DES).
Clinical follow up visits at 1, 6 and 12 months. Angiographic follow up visit at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Releasing Balloon | Experimental | Device: Paclitaxel Releasing BalloonPercutaneous coronary intervention with paclitaxel releasing balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient >/= 18 years
- Written patient informed consent available
- Patients with stable, unstable or documented silent angina pectoris
- Patient eligible for percutaneous coronary intervention
- Patient acceptable candidate for coronary artery bypass surgery
Key exclusion criteria (24 listed)
- Left ventricular ejection fraction of < 30%
- Visible thrombus in the target vessel visualized by angiography
- Myocardial infarction (STEMI/NSTEMI) within 72 hours of the intended treatment. Determination of CKMB and/or troponin T or I is required.
- Laboratory assessments to be done within 24 hours prior to intervention. Patients with CKMB and/or troponin T or I > 2 fold the upper limit of normal must not be included in the trial.
- Patients with planned major surgery within 3 months after planned coronary intervention and/or risk of either acetylsalicylic acid of clopidogrel cessation
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 Releasing BalloonAlso: Pantera LuxPercutaneous coronary intervention with paclitaxel releasing balloon | Device | Paclitaxel Releasing Balloon |
Primary outcome
In-stent Late Lumen Loss
Time frame: 6 months
In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon. Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA). Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).
9 secondary outcomes
In-segment Late Lumen Loss
Time frame: 6 months
Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)
Time frame: 6 months
Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)
Time frame: 12 months
In-stent Diameter Stenosis (%DS)
Time frame: 6 months
In-segment Diameter Stenosis (%DS)
Time frame: 6 months
Binary In-stent Restenosis
Time frame: 6 months
Binary In-segment Restenosis
Time frame: 6 months
Technical Success
Time frame: directly after intervention (after finalized treatment)
Device Success
Time frame: directly after intervention (after finalized treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22867706Hehrlein C, Dietz U, Kubica J, Jorgensen E, Hoffmann E, Naber C, Lesiak M, Schneider H, Wiemer M, Tolg R, Richardt G. Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial. Cardiovasc Revasc Med. 2012 Sep-Oct;13(5):260-4. doi: 10.1016/j.carrev.2012.06.002. Epub 2012 Aug 4.
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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, MD principal investigator
University Medical Center, Freiburg i.Br., Germany
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 Releasing Balloon in people with In-stent Coronary Artery Restenosis, run by Biotronik AG 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 9 inclusion and 24 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 6 May 2013. 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?
Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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-stent Late Lumen 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 NCT00961181, 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 6 May 2013; AzTrials last refreshed its copy on 8 Nov 2026.