First in Man Trial - BIOSOLVE-I

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2010 by Biotronik AG.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Biotronik AG

ClinicalTrials.gov Identifier:

NCT01168830

First received: July 22, 2010

Last updated: December 23, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 22, 2010
Last Updated Date	December 23, 2010
Start Date ^ICMJE	July 2010
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 22, 2010)	Target Lesion Failure
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01168830 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	First in Man Trial - BIOSOLVE-I
Official Title ^ICMJE	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)
Brief Summary	First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	de Novo Lesions in Native Coronary Arteries
Intervention ^ICMJE	Device: AMS-3.0
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 79 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Germany, Netherlands, Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01168830
Other Study ID Numbers ^ICMJE	C1007
Has Data Monitoring Committee	Yes
Responsible Party	Myriam Stieler, Biotronik AG
Study Sponsor ^ICMJE	Biotronik AG
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biotronik AG
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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