Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 1 for:    NCT01960504
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01960504
Recruitment Status : Unknown
Verified January 2020 by Biotronik AG.
Recruitment status was:  Active, not recruiting
First Posted : October 10, 2013
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Biotronik AG

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Stenosis Device: Percutaneous Coronary Intervention (DREAMS) stenting Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : October 2013
Actual Primary Completion Date : August 2015
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]
  2. Scaffold thrombosis rate [ Time Frame: 1, 6, 12, 24 and 36 months ]
  3. In-scaffold and in-segment Binary Restenosis Rate [ Time Frame: 6 and 12 months ]
  4. In-scaffold and in-segment Percent Diameter Stenosis [ Time Frame: 6 and 12 months ]
  5. Late Lumen Loss in segment [ Time Frame: 12 months ]
  6. Late Lumen Loss in scaffold [ Time Frame: 6 and 12 months ]
  7. 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.

  8. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01960504

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Michael Haude, MD Städtische Kliniken Neuss
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Biotronik AG Identifier: NCT01960504    
Other Study ID Numbers: C1209
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Biotronik AG:
Drug Eluting Absorbable Metal Scaffold
Coronary Artery Disease
Myocardial Ischemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases