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Coronary Artery DiseaseBIOSOLVE-IIINCT02716220

Pre-market Study of the DREAMS 2G Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-III)

A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Biotronik AG at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Percutaneous Coronary Intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
8 sitesin 4 countries
Study dates
Mar 2016to Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Reference vessel diameter between 2.7-3.8 mm by visual estimation, depending on the scaffold size used.
  • Target lesion length by visual estimation, assisted by QCA: < 21 mm, depending on the scaffold size used.
  • Target lesion stenosis by visual estimation, assisted by QCA > 50% - < 100%
  • Eligible for Dual Anti Platelet Therapy (DAPT)

Who cannot join

  • 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
  • Left main coronary artery disease
  • Three-vessel coronary artery disease at time of procedure
  • Thrombus in target vessel
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  • 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 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 directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
  • Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of DREAMS 2G and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can't be covered by a single scaffold), by visual estimation
  • Known allergies to: Acetylsalicylic Acid (ASA), Heparin, contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus, Tacrolimus), PLLA, Silicon Carbide Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum
  • Impaired renal function (serum creatinine > 2.5 mg/dl or 221mmol/l) determined within 72 hours prior to intervention
  • Subject is receiving oral or intravenous immuno-suppressive therapy ( 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, or other co-morbidities (e.g. Sepsis, Apoplexy or TIA within 6 months prior to the study procedure) (Co-morbidities definitions will be left to the discretion of the Study Investigators)
  • Planned surgery or dental surgical procedure within 6 months after index procedure
  • Subject with tortuous vessel that may impair scaffold placement in the region of obstruction or proximal to the lesion
  • In the investigators opinion subjects will not be able to comply with the follow-up Requirements

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Germany5 sites

  • Segeberger Kliniken GmbH

    Bad Segeberg, 23795

  • Vivantes Klinikum Friederichshain,

    Berlin, 10249

  • Amper Kliniken AG

    Dachau, 85221

  • Städtische Kliniken Neuss

    Neuss, 41464

  • Universitätsmedizin Rostock

    Rostock, 18057

Other trials in Germany

Belgium1 site

  • Interventional Cardiology Middelheim Hospital (ZNA Middelheim)

    Antwerp, 2020

Other trials in Belgium

Netherlands1 site

  • Thoraxcenter, Erasmus Medical Center

    Rotterdam, 3015 CE

Other trials in Netherlands

Switzerland1 site

  • Universitätsklinik Inselspitalspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official title: BIOTRONIKS - Acute Performance Of a Drug Eluting Absorbable Metal Scaffold (DREAMS 2G) in Patients With de Novo Lesions in NatiVE Coronary Arteries: BIOSOLVE-III

BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.

Being tested
Percutaneous Coronary Intervention
Keywords
DREAMS 2G, Scaffold, Drug Eluting Absorbable Metal Scaffold, Coronary Artery Disease
Medical subject headings
Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary InterventionDevice

    Implanttaion fo the DREAMS 2G Scaffold

Study groups in NCT02716220
Study groupRoleWhat they receive
'Percutaneous Coronary Intervention' /Scaffold ImplantationExperimentalPCI for enrolled subjects: implantation of the DREAMS 2G Drug-Eluting Coronary Scaffold System
Receives: Device: Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute performance of the DREAMS 2G

    Acute performance of the DREAMS 2G assessed by procedure success. Procedure success is defined as: Procedure Success is defined as achievement of a final diameter stenosis of <30% by QCA (using any percutaneous method) without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay

    Measured: During the hospital stay to a maximum of 7 days post study Procedure

Secondary outcomes (6)

  1. Target Lesion Failure (TLF)

    TLF defined as a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave Myocardial Infarction (MI)**, Coronary Artery Bypass Grafting (CABG), clinically driven Target Lesion Revascularization (TLR)

    Measured: 1, 6 12, 24 and 36 months post procedure

  2. Scaffold thrombosis rate

    Measured: 1, 6 12, 24 and 36 months post procedure

  3. Binary in-scaffold and in-segment restenosis rate

    Measured: 12-months

  4. % in-scaffold and in-segment diameter stenosis

    Measured: 12-months

  5. In-segment late lumen loss

    Measured: 12-months

  6. In-scaffold late lumen loss

    Measured: 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2017
  4. Study completionAug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716220
Sponsor's protocol ID
C1502
Acronym
BIOSOLVE-III
Status last verified
Jan 2020
First submitted
17 Mar 2016
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Biotronik AG at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Belgium, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute performance of the DREAMS 2G (time frame: During the hospital stay to a maximum of 7 days post study Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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