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

July 22, 2010
July 23, 2010
February 5, 2015
July 2010
December 2011   (Final data collection date for primary outcome measure)
Target Lesion Failure [ Time Frame: 6 and 12 months ]
Target Lesion Failure
Complete list of historical versions of study NCT01168830 on Archive Site
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First in Man Trial - BIOSOLVE-I
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)
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
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Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
de Novo Lesions in Native Coronary Arteries
Device: AMS-3.0
Experimental: Investigational device
Intervention: Device: AMS-3.0

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2014
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Netherlands,   Switzerland
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Biotronik AG
Biotronik AG
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Biotronik AG
February 2015

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