First in Man Trial - BIOSOLVE-I (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

Study Overview

• Status: Completed
• Conditions: de Novo Lesions in Native Coronary Arteries
• Intervention / Treatment: Device: AMS-3.0

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational device	Device: AMS-3.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target Lesion Failure	6 and 12 months

Collaborators and Investigators

• Sponsor: Biotronik AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (ESTIMATE): July 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: C1007