First in Man Trial - BIOSOLVE-I - Full Text View

Sponsor:	Biotronik AG
Information provided by:	Biotronik AG
ClinicalTrials.gov Identifier:	NCT01168830

Purpose

First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety

Condition	Intervention
de Novo Lesions in Native Coronary Arteries	Device: AMS-3.0

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	BIOTRONIKS-Safety and Clinical Performance Of the First Drug-Eluting Generation Absorbable Metal Stent In Patients With de Novo Lesions in NatiVE Coronary Arteries (BIOSOLVE - I)

Further study details as provided by Biotronik AG:

Primary Outcome Measures:

Target Lesion Failure

Study Start Date:	July 2010
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168830

Locations

Belgium
Middelheim Hospital
Antwerpen, Belgium
Germany
Universitätsklinik Essen, Westdeutsches Herzzentrum
Essen, Germany
Universitätsklinikum Freiburg
Freiburg, Germany
Lukaskrankenhaus Neuss
Neuss, Germany
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Switzerland
Luzerner Kantonsspital
Luzern, Switzerland

Sponsors and Collaborators

Biotronik AG

More Information

No publications provided

Responsible Party:	Myriam Stieler, Biotronik AG
ClinicalTrials.gov Identifier:	NCT01168830 History of Changes
Other Study ID Numbers:	C1007
Study First Received:	July 22, 2010
Last Updated:	December 23, 2010
Health Authority:	Germany: Bundesinstitut für Arzneimittel und Medizinprodukte; Switzerland: Swissmedic; Belgium: Federal Agency for Medicines and Health Products; The Netherlands: EC Catharina Ziekenhuis, Eindhoven

ClinicalTrials.gov processed this record on February 09, 2012