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Pre-market Study of the DREAMS 2G Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-III) | Clinical Trials | Clareo Health

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

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

NCT02716220•Biotronik AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is \> 18 years and \< 80 years of age
•2. Written subject informed consent available prior to PCI
•3. Subjects with stable or unstable angina pectoris or documented silent ischemia
•4. Subject eligible for PCI
•5. Subject acceptable candidate for coronary artery bypass surgery
•6. Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
•7. Reference vessel diameter between 2.7-3.8 mm by visual estimation, depending on the scaffold size used.
•8. Target lesion length by visual estimation, assisted by QCA: \< 21 mm, depending on the scaffold size used.
•9. Target lesion stenosis by visual estimation, assisted by QCA \> 50% - \< 100%
•10. Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion Criteria

•1. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
•2. Evidence of myocardial infarction within 72 hours prior to index procedure
•3. 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
•4. Left main coronary artery disease
•5. Three-vessel coronary artery disease at time of procedure
•6. Thrombus in target vessel
•7. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
•8. Planned interventional treatment of any non-target vessel within 30 days post procedure
•9. Subjects on dialysis
•10. Planned intervention of the target vessel after the index procedure
+15 more criteria

Locations (8)

Interventional Cardiology Middelheim Hospital (ZNA Middelheim)

Antwerp, Belgium

Segeberger Kliniken GmbH

Bad Segeberg, Germany

Vivantes Klinikum Friederichshain,

Berlin, Germany

Amper Kliniken AG

Dachau, Germany

Städtische Kliniken Neuss

Neuss, Germany

Universitätsmedizin Rostock

Rostock, Germany

Thoraxcenter, Erasmus Medical Center

Rotterdam, Netherlands

Universitätsklinik Inselspitalspital Bern

Bern, Switzerland

Key Dates

Start Date

March 1, 2016

Primary Completion Date

December 1, 2017

Completion Date

August 1, 2019

Last Updated

January 18, 2020

Enrollment

ACTUAL participants

Conditions

Coronary Artery DiseaseCoronary Artery Stenosis

Interventions

Percutaneous Coronary Intervention

DEVICE

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

NCT05681702

Coronary Artery Disease

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RECRUITING

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

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