Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

Not Applicable

Completed

Conditions: In-stent Coronary Artery Restenosis

Interventions: Device: Paclitaxel Releasing Balloon

Registration Number: NCT00961181

Lead Sponsor: Biotronik AG

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel Releasing Balloon	Paclitaxel Releasing Balloon	Percutaneous coronary intervention with paclitaxel releasing balloon

Primary Outcome Measures

Name	Time	Method
In-stent Late Lumen Loss	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 Outcome Measures

Name	Time	Method
In-segment Late Lumen Loss	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).
Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)	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
Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)	12 months	All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.
In-stent Diameter Stenosis (%DS)	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).
In-segment Diameter Stenosis (%DS)	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).
Binary In-stent Restenosis	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).
Binary In-segment Restenosis	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).
Technical Success	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).
Device Success	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).