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Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis (PEPPER)

Primary Purpose

In-stent Coronary Artery Restenosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Paclitaxel Releasing Balloon
Sponsored by
Biotronik AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for In-stent Coronary Artery Restenosis focused on measuring paclitaxel, in-stent restenosis, BMS-ISR, DES-ISR, drug eluting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient >/= 18 years
  2. Written patient informed consent available
  3. Patients with stable, unstable or documented silent angina pectoris
  4. Patient eligible for percutaneous coronary intervention
  5. Patient acceptable candidate for coronary artery bypass surgery
  6. Patients with a single restenotic lesion in a previously stented area of a coronary artery (irrelevant whether BMS or DES related)
  7. Target reference vessel diameter (visual estimation): 2 - 4 mm
  8. Target lesion length (visual estimation): 8 - 28 mm
  9. Target lesion stenosis (visual estimation): >/= 50% - < 100%

Exclusion Criteria:

  1. Left ventricular ejection fraction of < 30%
  2. Visible thrombus in the target vessel visualized by angiography

  3. 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.

  4. Patients with planned major surgery within 3 months after planned coronary intervention and/or risk of either acetylsalicylic acid of clopidogrel cessation
  5. Lesion length longer than length of available treatment balloon
  6. Impaired renal function (serum creatinine > 2.0mg/dl or 177 micro mol/l, determined within 72 hours prior to intervention)
  7. Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
  8. Totally occluded coronary artery (Mehran classification IV and TIMI flow 0)
  9. Target lesion located in vessel bifurcation
  10. Previous and/or planned brachytherapy of target vessel
  11. Target lesion located in left main coronary artery
  12. Stroke or TIA < 6 months prior to procedure
  13. Patient with signs of a cardiogenic shock
  14. Patient under ongoing systemic immunosuppressive therapy with paclitaxel or agents of the -limus group (i.e. sirolimus, tacrolimus, everolimus)
  15. Surgeries of any kind within 30 days prior to screening
  16. Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
  17. Known allergies to anti-platelet-, anticoagulation therapy, contrast media or paclitaxel
  18. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required for females of child-bearing potential)
  19. Patient with a life expectancy of less than one year
  20. Patient currently enrolled in other investigational device or drug trial
  21. Patient with known incompliance to medical (antiplatelet, anticoagulation) therapy
  22. Patient not able or willing to adhere to follow-up visits including follow-up angiography

Sites / Locations

  • Prof. Dr. Christoph Hehrlein

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel Releasing Balloon

Arm Description

Percutaneous coronary intervention with paclitaxel releasing balloon

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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
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.
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).
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).
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).
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).
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).
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).

Full Information

First Posted
August 13, 2009
Last Updated
May 2, 2013
Sponsor
Biotronik AG
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1. Study Identification

Unique Protocol Identification Number
NCT00961181
Brief Title
Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis
Acronym
PEPPER
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In-stent Coronary Artery Restenosis
Keywords
paclitaxel, in-stent restenosis, BMS-ISR, DES-ISR, drug eluting balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel Releasing Balloon
Arm Type
Experimental
Arm Description
Percutaneous coronary intervention with paclitaxel releasing balloon
Intervention Type
Device
Intervention Name(s)
Paclitaxel Releasing Balloon
Other Intervention Name(s)
Pantera Lux
Intervention Description
Percutaneous coronary intervention with paclitaxel releasing balloon
Primary Outcome Measure Information:
Title
In-stent Late Lumen Loss
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
In-segment Late Lumen Loss
Description
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).
Time Frame
6 months
Title
Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)
Description
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
Time Frame
6 months
Title
Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)
Description
All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.
Time Frame
12 months
Title
In-stent Diameter Stenosis (%DS)
Description
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).
Time Frame
6 months
Title
In-segment Diameter Stenosis (%DS)
Description
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).
Time Frame
6 months
Title
Binary In-stent Restenosis
Description
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).
Time Frame
6 months
Title
Binary In-segment Restenosis
Description
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).
Time Frame
6 months
Title
Technical Success
Description
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).
Time Frame
directly after intervention (after finalized treatment)
Title
Device Success
Description
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).
Time Frame
directly after intervention (after finalized treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Target reference vessel diameter (visual estimation): 2 - 4 mm Target lesion length (visual estimation): 8 - 28 mm Target lesion stenosis (visual estimation): >/= 50% - < 100% 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Hehrlein, MD
Organizational Affiliation
University Medical Center, Freiburg i.Br., Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Dr. Christoph Hehrlein
City
Freiburg
ZIP/Postal Code
79106
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22867706
Citation
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.
Results Reference
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Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

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