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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.
ClinicalTrials.gov Identifier: NCT01168830
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : February 5, 2015
Information provided by (Responsible Party):
Biotronik AG

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

Condition or disease Intervention/treatment Phase
de Novo Lesions in Native Coronary Arteries Device: AMS-3.0 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Investigational device Device: AMS-3.0

Primary Outcome Measures :
  1. Target Lesion Failure [ Time Frame: 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168830

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Middelheim Hospital
Antwerpen, Belgium
Universitätsklinik Essen, Westdeutsches Herzzentrum
Essen, Germany
Universitätsklinikum Freiburg
Freiburg, Germany
Lukaskrankenhaus Neuss
Neuss, Germany
Catharina Ziekenhuis
Eindhoven, Netherlands
Luzerner Kantonsspital
Luzern, Switzerland
Sponsors and Collaborators
Biotronik AG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01168830    
Other Study ID Numbers: C1007
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015