First in Man Trial - BIOSOLVE-I | NCT01168830

Studies
First in Man Trial - BIOSOLVE-I

NCT01168830

Sponsor

Biotronik AG

Status

Completed

Last Update Posted

Feb 5, 2015Estimated

Enrollment

46Actual

Phase

Not Applicable

Conditions

de Novo Lesions in Native Coronary Arteries

Interventions

AMS-3.0

Countries

Belgium
Germany
Netherlands
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jul 22, 2010

First Submission Date that Met QC Criteria

Jul 22, 2010

First Posted Date

Jul 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2015

Last Update Posted Date

Feb 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Label	Type	Description	Intervention Names
Investigational device	Experimental		Device: AMS-3.0

Name	Type	Description	Arm Group Labels	Other Names
AMS-3.0	Device		Investigational device

Measure	Description	Time Frame
Target Lesion Failure		6 and 12 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Middelheim Hospital		Antwerp			Belgium
Universitätsklinik Essen, Westdeutsches Herzzentrum

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24254708	Derived	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.
23332165