First in Man Trial - BIOSOLVE-I (BIOSOLVE-I)

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Waksman R, Prati F, Bruining N, Haude M, Bose D, Kitabata H, Erne P, Verheye S, Degen H, Vermeersch P, Di Vito L, Koolen J, Erbel R. Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment. Circ Cardiovasc Interv. 2013 Dec;6(6):644-53. doi: 10.1161/CIRCINTERVENTIONS.113.000693. Epub 2013 Nov 19.

Haude M, Erbel R, Erne P, Verheye S, Degen H, Bose D, Vermeersch P, Wijnbergen I, Weissman N, Prati F, Waksman R, Koolen J. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet. 2013 Mar 9;381(9869):836-44. doi: 10.1016/S0140-6736(12)61765-6.

• Responsible Party: Biotronik AG
• ClinicalTrials.gov Identifier: NCT01168830
• Other Study ID Numbers: C1007
• First Posted: July 23, 2010
• Last Update Posted: February 5, 2015
• Last Verified: February 2015