Status:
COMPLETED
Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis
Lead Sponsor:
Biotronik AG
Conditions:
In-stent Coronary Artery Restenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 visi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00961181
Start Date
August 1 2009
End Date
May 1 2011
Last Update
May 6 2013
Active Locations (1)
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1
Prof. Dr. Christoph Hehrlein
Freiburg im Breisgau, Germany, 79106