First in Man Trial - BIOSOLVE-I

NCT01168830 | Completed DMC

• 1 other identifier: C1007
• Study Type: interventional
• Target: 46
• Locations: 4 countries
• Sites: 6

Brief Summary

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

Conditions

de Novo Lesions in Native Coronary Arteries

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure

  6 and 12 months

Study Arms (1)

Investigational device

EXPERIMENTAL

Device: AMS-3.0

Interventions

AMS-3.0 DEVICE

Investigational device

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (6)

Middelheim Hospital

Antwerp, Belgium

Location

Universitätsklinik Essen, Westdeutsches Herzzentrum

Essen, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Lukaskrankenhaus Neuss

Neuss, Germany

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 24254708 DERIVED

• 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.

  PMID: 23332165 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2014
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

DE (3); NL (1); BE (1); CH (1)