First in Man Trial - BIOSOLVE-I

de Novo Lesions in Native Coronary Arteries Clinical Trial

— BIOSOLVE-I  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168830
• Other study ID #: C1007
• Status: Completed
• Phase: N/A
• First received: July 22, 2010
• Last updated: February 4, 2015
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und MedizinprodukteSwitzerland: SwissmedicBelgium: Federal Agency for Medicines and Health Products, FAMHPThe Netherlands: EC Catharina Ziekenhuis, Eindhoven
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• de Novo Lesions in Native Coronary Arteries

Intervention

Device:
• AMS-3.0

Locations

Country	Name	City	State
Belgium	Middelheim Hospital	Antwerpen
Germany	Universitätsklinik Essen, Westdeutsches Herzzentrum	Essen
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Lukaskrankenhaus Neuss	Neuss
Netherlands	Catharina Ziekenhuis	Eindhoven
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure		6 and 12 months	Yes