NCT04157153

Brief Summary

A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
9mo left

Started Apr 2020

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
8 countries

14 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Apr 2020Feb 2027

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

November 6, 2019

Last Update Submit

July 20, 2022

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • In scaffold late lumen loss

    Independent Core Lab Assessment

    At 6 months after index procedure

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months.

Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Interventions

Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium ScaffoldDEVICE

Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold

Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is \> 18 years and \< 80 years of age
  • Written subject informed consent available prior to PCI
  • Subject eligible for PCI
  • Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions and can be covered with 1 device each
  • Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used
  • Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used
  • Target lesion stenosis by visual estimation \> 50% - \< 100% and TIMI flow ≥1 (assisted by e.g. QCA / IVUS /FFR).
  • Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion
  • Eligible for Dual Anti Platelet Therapy (DAPT)

You may not qualify if:

  • Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
  • Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
  • Left main coronary artery disease
  • Three-vessels with coronary artery disease requiring treatment at time of procedure
  • Planned interventional treatment of any non-target vessel within 12-month post-procedure
  • Subjects on dialysis
  • Planned intervention of the target vessel post 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% within the last 6 months
  • Heavily calcified lesion
  • Target lesion is located in or supplied by an arterial or venous bypass graft
  • Target lesion requiring treatment with a device other than the non-compliant pre-dilatation balloon or scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.)
  • Unsuccessful pre-dilatation, defined as a residual stenosis rate more than 20%, estimated by any method and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
  • Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Medizinische Universität Graz

Graz, Austria

Location

Algemeen Ziekenhuis Middelheim

Antwerp, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, Belgium

Location

Segeberger Kliniken

Bad Segeberg, Germany

Location

Herz-und Gefäßzentrum Oberallgäu-Kempten

Kempten, Germany

Location

Johannes Wesling Klinikum Minden

Minden, Germany

Location

Deutsches Herzzentrum

Münich, Germany

Location

Rheinland Klinikum Lukaskrankenhaus Neuss

Neuss, Germany

Location

Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)

Amsterdam, Netherlands

Location

Miedziowe Centrum Zdrowia SA

Lubin, Poland

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Lund University Hospital

Lund, Sweden

Location

University Hospital Geneva HUG

Geneva, Switzerland

Location

Related Publications (3)

  • Aytekin A, Seguchi M, Xhepa E, Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Garcia-Garcia HM, Waksman R, Joner M. The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months. Catheter Cardiovasc Interv. 2025 Jun;105(7):1563-1571. doi: 10.1002/ccd.31486. Epub 2025 Mar 16.

    PMID: 40091374DERIVED

  • Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth GG, Joner M, Toelg R, Wiemer M, Olivecrano G, Vermeersch P, Garcia-Garcia HM, Waksman R. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study. EuroIntervention. 2023 Aug 7;19(5):e414-e422. doi: 10.4244/EIJ-D-23-00326.

    PMID: 37334655DERIVED

  • Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth G, Joner M, Toelg R, Wiemer M, Olivecrona G, Vermeersch P, Garcia-Garcia HM, Waksman R. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study. EClinicalMedicine. 2023 Apr 17;59:101940. doi: 10.1016/j.eclinm.2023.101940. eCollection 2023 May.

    PMID: 37113674DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Michael Haude, Prof

    Rheinland Klinikum Lukaskrankenhaus Neuss

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

April 27, 2020

Primary Completion

August 1, 2022

Study Completion (Estimated)

February 1, 2027

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)ES(1)CH(1)AU(1)DE(5)BE(3)SE(1)PL(1)