Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

Biotronik AG81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

In-stent Coronary Artery Restenosis

Interventions

Paclitaxel Releasing BalloonDEVICE

Percutaneous coronary intervention with paclitaxel releasing balloon

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prof. Dr. Christoph Hehrlein

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

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).

Time frame: 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

Time frame: 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.

Time frame: 12 months

In-stent Diameter Stenosis (%DS)

Data from ClinicalTrials.gov

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