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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Biotronik AG
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01960504
First received: October 6, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • In segment Late Lumen Loss [ Time Frame: 6 months post index procedure ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Scaffold thrombosis rate [ Time Frame: 1, 6, 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
  • In-scaffold and in-segment Binary Restenosis Rate [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • In-scaffold and in-segment Percent Diameter Stenosis [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Late Lumen Loss in segment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Late Lumen Loss in scaffold [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Procedure success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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
Study Start Date: October 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960504

Contacts
Contact: Banu Eyueboglu Seitz, PhD +41 44 864 5872 banu.eyueboglu.seitz@biotronik.com
Contact: Tamara Koch +41 44 864 58 77 tamara.koch@biotronik.com

Locations
Belgium
OLV-Ziekenhuis Aalst Not yet recruiting
Aalst, Belgium, 9300
Contact: William Wijns, MD         
Principal Investigator: William Wijns, MD         
Brazil
Instituto do Coração - HCFMUSP Not yet recruiting
São Paulo, Brazil, 05403-000
Contact: Pedro A. Lemos, MD         
Principal Investigator: Pedro A. Lemos, MD         
Instituto Dante Pazzanese de Cardiologia Not yet recruiting
São Paulo, Brazil, 04012-909
Contact: Alexandre Abizaid         
Principal Investigator: Alexandre Abizaid, MD         
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8200
Contact: Evald Høj Christiansen, MD         
Principal Investigator: Evald Høj Christiansen, MD         
Germany
Universitäts-Herzzentrum Freiburg Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Franz-Josef Neumann, MD         
Principal Investigator: Franz-Josef Neumann, MD         
Segeberg Kliniken GmbH, Herzzentrum Recruiting
Bad Segeberg, Germany, D-23795
Contact: Ralph Tölg, MD         
Principal Investigator: Ralph Tölg, MD         
Städtische Kliniken Neuss - Lukaskrankenhaus Recruiting
Neuss, Germany, 41464
Contact: Michael Haude, MD         
Principal Investigator: Michael Haude, MD         
Netherlands
Thoraxcentrum Twente Not yet recruiting
Enschede, Netherlands, 7513ER
Contact: Clemens von Birgelen, MD         
Principal Investigator: Clemens von Birgelen, MD         
Singapore
National Heart Centre Singapore Not yet recruiting
Mistri Wing, Singapore, 168752
Contact: Lim Soo Teik, MD         
Principal Investigator: Lim Soo Teik, MD         
Spain
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Contact: Nieves Gonzalo Lopez, MD         
Principal Investigator: Nieves Gonzalo Lopez, MD         
Switzerland
University Hospital Basel Not yet recruiting
Basel, Switzerland, CH-4031
Contact: Christoph Kaiser, MD         
Principal Investigator: Christoph Kaiser, MD         
CHUV - Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Switzerland, 1011
Contact: Eric Eeckhout, MD         
Principal Investigator: Eric Eeckhout, MD         
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Michael Haude, MD Städtische Kliniken Neuss
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01960504     History of Changes
Other Study ID Numbers: C1209
Study First Received: October 6, 2013
Last Updated: October 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic
Netherlands: Dutch Health Care Inspectorate
Denmark: Danish Health and Medicines Authority
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Singapore: Health Sciences Authority

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

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Coronary Stenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014