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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT00961181
First received: August 13, 2009
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
In-stent Coronary Artery Restenosis
Device: Paclitaxel Releasing Balloon

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • In-stent Late Lumen Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.

  • In-stent Diameter Stenosis (%DS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: directly after intervention (after finalized treatment) ] [ Designated as safety issue: No ]

    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 [ Time Frame: directly after intervention (after finalized treatment) ] [ Designated as safety issue: No ]

    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).



Enrollment: 81
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel Releasing Balloon
Percutaneous coronary intervention with paclitaxel releasing balloon
Device: Paclitaxel Releasing Balloon
Percutaneous coronary intervention with paclitaxel releasing balloon
Other Name: Pantera Lux

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961181

Locations
Germany
Prof. Dr. Christoph Hehrlein
Freiburg, Germany, 79106
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Christoph Hehrlein, MD University Medical Center, Freiburg i.Br., Germany
  More Information

Publications:
Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT00961181     History of Changes
Other Study ID Numbers: C0902
Study First Received: August 13, 2009
Results First Received: March 19, 2013
Last Updated: May 2, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information
Denmark: Danish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Biotronik AG:
paclitaxel
in-stent restenosis
BMS-ISR
DES-ISR
drug eluting balloon

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014