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Completed

NCT Number: NCT00961181

Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

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.

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Key information

Conditions

In-Stent Coronary Artery Restenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Christoph Hehrlein

Freiburg im Breisgau, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel Releasing Balloon

Device

Percutaneous coronary intervention with paclitaxel releasing balloon

Other names: Pantera Lux

Primary outcomes

  1. 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).

Secondary outcomes

  1. In-segment Late Lumen Loss

    Time frame: 6 months

    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. 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

    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

  3. Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)

    Time frame: 12 months

    All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.

  4. In-stent Diameter Stenosis (%DS)

    Time frame: 6 months

    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).

  5. In-segment Diameter Stenosis (%DS)

    Time frame: 6 months

    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. Binary In-stent Restenosis

    Time frame: 6 months

    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).

  7. Binary In-segment Restenosis

    Time frame: 6 months

    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).

  8. Technical Success

    Time frame: directly after intervention (after finalized treatment)

    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).

  9. Device Success

    Time frame: directly after intervention (after finalized treatment)

    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).

Sponsors and collaborators

Lead sponsor

Biotronik AG

Industry

Registry information

Official study 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

Acronym: PEPPER

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 18, 2009
Registry last updated
May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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