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

January 14, 2020 updated by: Biotronik AG

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • OLV-Ziekenhuis Aalst
  • Brazil
      • São Paulo, Brazil, 04012-909
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, Brazil, 05403-000
        • Instituto do Coração - HCFMUSP
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
  • Germany
      • Bad Krozingen, Germany, 79189
        • Universitäts-Herzzentrum Freiburg Bad Krozingen
      • Bad Segeberg, Germany, D-23795
        • Segeberg Kliniken GmbH, Herzzentrum
      • Berlin, Germany
        • Vivantes Klinikum
      • Neuss, Germany, 41464
        • Stadtische Kliniken Neuss - Lukaskrankenhaus
  • Netherlands
      • Enschede, Netherlands, 7513ER
        • Thoraxcentrum Twente
  • Singapore
      • Mistri Wing, Singapore, 168752
        • National Heart Centre Singapore
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
  • Switzerland
      • Basel, Switzerland, CH-4031
        • University Hospital Basel
      • Lausanne, Switzerland, 1011
        • CHUV - Centre hospitalier universitaire vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug Eluting Absorbable Metal Scaffold
DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
Device: Percutaneous Coronary Intervention (DREAMS) stenting
Other Names:
  • DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In segment Late Lumen Loss
Time Frame: 6 months post index procedure
6 months post index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 6, 12, 24 and 36 months
Scaffold thrombosis rate
Time Frame: 1, 6, 12, 24 and 36 months
1, 6, 12, 24 and 36 months
In-scaffold and in-segment Binary Restenosis Rate
Time Frame: 6 and 12 months
6 and 12 months
In-scaffold and in-segment Percent Diameter Stenosis
Time Frame: 6 and 12 months
6 and 12 months
Late Lumen Loss in segment
Time Frame: 12 months
12 months
Late Lumen Loss in scaffold
Time Frame: 6 and 12 months
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.
During the hospital stay to a maximum of the first seven days post index procedure
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik AG

Investigators

  • Principal Investigator: Michael Haude, MD, Städtische Kliniken Neuss

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

October 6, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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