Status:
COMPLETED
First in Man Trial - BIOSOLVE-I
Lead Sponsor:
Biotronik AG
Conditions:
de Novo Lesions in Native Coronary Arteries
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
Eligibility Criteria
Inclusion
- Patient is \> 18 years and \< 80 years of age
- Written patient informed consent available prior to PCI
- Patients with stable or unstable angina pectoris or documented silent ischemia
- Patient eligible for PCI
- Patient acceptable candidate for coronary artery bypass surgery
Exclusion
- Left ventricular ejection fraction of \< 30%
- Presence of a visible thrombus in the target vessel visualized by angiography
- Lesion and/or way to lesion extremely calcified (e.g. IVUS catheter can not reach/cross the lesion)
- Patients with three-vessel where all three vessels require treatment
- Patients with previous CABG in the target vessel(s)
- Patients with known coronary artery spasm
- Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required.
- Patients with planned major surgery within 12 months after coronary intervention
- Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation
- Patients under current Phenprocoumon or Cumarine therapy
- Impaired renal function (serum creatinine \> 2.0mg/dl or 177micromol/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 (TIMI flow 0)
- Lesions located within arterial or venous graft
- Ostial lesions
- 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
- Surgeries of any kind within 30 days prior to screening
- Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
- Pregnant and/or breast-feeding females or females who intend to become pregnant
- Patient currently enrolled in other investigational device or drug trial
- Patient with expected incompliance to medical (antiplatelet, anticoagulation) therapy
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01168830
Start Date
July 1 2010
End Date
December 1 2014
Last Update
February 5 2015
Active Locations (6)
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1
Middelheim Hospital
Antwerp, Belgium
2
Universitätsklinik Essen, Westdeutsches Herzzentrum
Essen, Germany
3
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
4
Lukaskrankenhaus Neuss
Neuss, Germany