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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel Releasing Balloon | Experimental | Percutaneous coronary intervention with paclitaxel releasing balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel Releasing Balloon | Device | Percutaneous coronary intervention with paclitaxel releasing balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Hehrlein, MD | University Medical Center, Freiburg i.Br., Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. Christoph Hehrlein | Freiburg im Breisgau | 79106 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22867706 | Result | 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. |
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No group assignment.
From 14 August 2009 to 26 April 2010 a total of 81 patients at 9 heart centres in Europe were enrolled. Last follow-up was completed 09 May 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel Releasing Balloon | Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel Releasing Balloon | Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA | Posted | Mean | Standard Deviation | mm | 6 months |
|
1 year
On-site follow up at 6 and 12 month follow up. All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paclitaxel Releasing Balloon | Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac death | Cardiac disorders | Systematic Assessment |
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Single arm design. Optimal time point for a quantitative angiographic follow up should be scheduled after 12 months, as recommended by the Academic Research Consortium guidelines for DES.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Christoph Hehrlein | University Medical Center, Freiburg i.Br., Germany | +49 761 270 | 6095 | christoph.hehrlein@uniklinik-freiburg.de |
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| 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 | 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. | 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). | 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). | 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). | 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). | 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). | 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). | directly after intervention (after finalized treatment) |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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). | 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA | Posted | Mean | Standard Deviation | mm | 6 months |
|
|
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| Secondary | 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 | 2 patients died, 2 patients withdrew consent | Posted | Number | participants | 6 months |
|
|
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| Secondary | 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. | 2 patients died, 2 patients withdrew consent, 1 patient lost to follow up | Posted | Number | participants | 12 months |
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|
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| Secondary | 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). | 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA | Posted | Mean | Standard Deviation | percentage of re-narrowing | 6 months |
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| Secondary | 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). | 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA | Posted | Mean | Standard Deviation | percentage of re-narrowing | 6 months |
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| Secondary | 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). | 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA | Posted | Number | participants | 6 months |
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| Secondary | 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). | 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA | Posted | Number | participants | 6 months |
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| Secondary | 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). | Posted | Number | participants | directly after intervention (after finalized treatment) |
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| Secondary | 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). | Posted | Number | participants | directly after intervention (after finalized treatment) |
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| 11 |
| 76 |
| 0 |
| 76 |
| Non-fatal myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Target vessel revascularization | Vascular disorders | Systematic Assessment |
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| Target lesion revascularization | Vascular disorders | Systematic Assessment |
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| Non-cardiac death | General disorders | Systematic Assessment |
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| Stent thrombosis | Vascular disorders | Systematic Assessment |
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