First in Man Trial - BIOSOLVE-I

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-12-31

Brief Summary

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

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Detailed Description

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Conditions

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de Novo Lesions in Native Coronary Arteries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational device

Group Type EXPERIMENTAL

AMS-3.0

Intervention Type DEVICE

Interventions

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AMS-3.0

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No