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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
  Purpose

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


Condition Intervention
de Novo Lesions in Native Coronary Arteries
 Device: AMS-3.0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • Target Lesion Failure

Study Start Date: July 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168830

Locations
Belgium
Middelheim Hospital
Antwerpen, Belgium
Germany
Universitätsklinik Essen, Westdeutsches Herzzentrum
Essen, Germany
Universitätsklinikum Freiburg
Freiburg, Germany
Lukaskrankenhaus Neuss
Neuss, Germany
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Switzerland
Luzerner Kantonsspital
Luzern, Switzerland
Sponsors and Collaborators
Biotronik AG
  More Information

No publications provided

Responsible Party: Myriam Stieler, Biotronik AG
ClinicalTrials.gov Identifier: NCT01168830     History of Changes
Other Study ID Numbers: C1007
Study First Received: July 22, 2010
Last Updated: December 23, 2010
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Switzerland: Swissmedic
Belgium: Federal Agency for Medicines and Health Products, FAMHP
The Netherlands: EC Catharina Ziekenhuis, Eindhoven

ClinicalTrials.gov processed this record on June 17, 2013