First in Man Trial - BIOSOLVE-I

This study has been completed.
Information provided by (Responsible Party):
Biotronik AG Identifier:
First received: July 22, 2010
Last updated: February 4, 2015
Last verified: February 2015

July 22, 2010
February 4, 2015
July 2010
December 2011   (final data collection date for primary outcome measure)
Target Lesion Failure [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
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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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.
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
18 Years to 79 Years
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Netherlands,   Switzerland
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