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First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II) (BIOSOLVE-II)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Biotronik AG Identifier:
First received: October 6, 2013
Last updated: February 2, 2017
Last verified: February 2017
BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

Condition Intervention
Coronary Artery Disease
Coronary Artery Stenosis
Device: Percutaneous Coronary Intervention (DREAMS) stenting

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • In segment Late Lumen Loss [ Time Frame: 6 months post index procedure ]

Secondary Outcome Measures:
  • Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR) [ Time Frame: 1, 6, 12, 24 and 36 months ]
  • Scaffold thrombosis rate [ Time Frame: 1, 6, 12, 24 and 36 months ]
  • In-scaffold and in-segment Binary Restenosis Rate [ Time Frame: 6 and 12 months ]
  • In-scaffold and in-segment Percent Diameter Stenosis [ Time Frame: 6 and 12 months ]
  • Late Lumen Loss in segment [ Time Frame: 12 months ]
  • Late Lumen Loss in scaffold [ Time Frame: 6 and 12 months ]
  • Procedure success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ]
    Procedure Success defined as achievement of a final diameter stenosis of <30% by QCA, using any percutaneous method, without the occurrence of death, Q-wave or WHO defined non-Q-wave, or repeat revascularization of the target lesion during the hospital stay.

  • Device success [ Time Frame: Day 0 ]

    Device Success is defined as a final residual diameter stenosis of <30% by QCA, using the assigned device only

    • successful delivery of the scaffold to the target lesion site in the coronary artery
    • appropriate scaffold deployment
    • successful removal of the device
    • safe removal of the device in case of deployment failure

Estimated Enrollment: 121
Actual Study Start Date: October 2013
Estimated Study Completion Date: February 2018
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Eluting Absorbable Metal Scaffold
DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
Device: Percutaneous Coronary Intervention (DREAMS) stenting
Other Name: DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is > 18 years and < 80 years of age
  • Written subject informed consent available prior to PCI
  • Subjects with stable or unstable angina pectoris or documented silent ischemia
  • Subject eligible for PCI
  • Subject acceptable candidate for coronary artery bypass surgery
  • Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
  • Reference vessel diameter between 2.2-3.8 mm by visual estimation
  • Target lesion length ≤ 21 mm by visual estimation
  • Target lesion stenosis by visual estimation, assisted by QCA / IVUS: > 50% - < 100%
  • Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion Criteria:

  • Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
  • Evidence of myocardial infarction within 72 hours prior to index procedure
  • Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
  • Unprotected left main coronary artery disease
  • Three-vessel coronary artery disease at time of procedure
  • Thrombus in target vessel
  • Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
  • Planned interventional treatment of any non-target vessel within 30 days post-procedure
  • Subjects on dialysis
  • Planned intervention of the target vessel within 6-month after the index procedure
  • Ostial target lesion (within 5.0 mm of vessel origin)
  • Target lesion involves a side branch >2.0 mm in diameter
  • Documented left ventricular ejection fraction (LVEF) ≤ 30%
  • Heavily calcified lesion
  • Target lesion is located in or supplied by an arterial or venous bypass graft
  • The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.)
  • Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
  • Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
  • Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
  • Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
  • Life expectancy less than 1 year
  • Planned surgery or dental surgical procedure within 6 months after index procedure
  • In the investigators opinion subjects will not be able to comply with the follow-up requirements
  Contacts and Locations
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Please refer to this study by its identifier: NCT01960504

OLV-Ziekenhuis Aalst
Aalst, Belgium, 9300
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 04012-909
Instituto do Coração - HCFMUSP
São Paulo, Brazil, 05403-000
Aarhus University Hospital
Aarhus, Denmark, 8200
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany, 79189
Segeberg Kliniken GmbH, Herzzentrum
Bad Segeberg, Germany, D-23795
Vivantes Klinikum
Berlin, Germany
Städtische Kliniken Neuss - Lukaskrankenhaus
Neuss, Germany, 41464
Thoraxcentrum Twente
Enschede, Netherlands, 7513ER
National Heart Centre Singapore
Mistri Wing, Singapore, 168752
Hospital Clinico San Carlos
Madrid, Spain, 28040
University Hospital Basel
Basel, Switzerland, CH-4031
CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Biotronik AG
Principal Investigator: Michael Haude, MD Städtische Kliniken Neuss
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Biotronik AG Identifier: NCT01960504     History of Changes
Other Study ID Numbers: C1209
Study First Received: October 6, 2013
Last Updated: February 2, 2017

Keywords provided by Biotronik AG:
Drug Eluting Absorbable Metal Scaffold
Coronary Artery Disease
Myocardial Ischemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 25, 2017