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First in Man Trial - BIOSOLVE-I (BIOSOLVE-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01168830
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : February 5, 2015
Information provided by (Responsible Party):
Biotronik AG

Tracking Information
First Submitted Date  ICMJE July 22, 2010
First Posted Date  ICMJE July 23, 2010
Last Update Posted Date February 5, 2015
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
Target Lesion Failure [ Time Frame: 6 and 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
Target Lesion Failure
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE de Novo Lesions in Native Coronary Arteries
Intervention  ICMJE Device: AMS-3.0
Study Arms  ICMJE Experimental: Investigational device
Intervention: Device: AMS-3.0
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2015)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2014
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Netherlands,   Switzerland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01168830
Other Study ID Numbers  ICMJE C1007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotronik AG
Study Sponsor  ICMJE Biotronik AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biotronik AG
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP