Clinical trial NCT01168830: First in Man 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: de Novo Lesions in Native Coronary Arteries
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Target Lesion Failure
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Middelheim Hospital
city: Essen
country: Germany
facility: Universitätsklinik Essen, Westdeutsches Herzzentrum
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Neuss
country: Germany
facility: Lukaskrankenhaus Neuss
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
References:
citation: 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.
citation: 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.