3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Stents in NSTE/ACS

NCT06409117 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: RESORB-ACS
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 7

Brief Summary

This is a multicentre, prospective, randomized controlled trial that will investigate the role and performance of the 3rd generation resorbable magnesium scaffolds "DREAMS 3G" labeled under the name "Freesolve" vs contemporary biodegradable polymer scaffolds in non ST-segment elevation acute coronary syndromes. Patients fulfilling the eligibility criteria will be enrolled and undergo PCI with either Freesolve or Orsiro platforms for the culprit lesion only. They will be followed-up for 12 months (1, 6 and 12 months). The primary endopoint will be Target Lesion Failure as defined by ARC definitions.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Keywords

PCI; NSTE/ACS; resorbable magnesium scaffolds; Scaffolds

Outcome Measures

Primary Outcomes (1)

• Target lesion failure rates

  cardiovascular death, myocardial infarction (target vessel) and target lesion renascularization (clinically driven)

  12 months

Secondary Outcomes (6)

• Target lesion revascularization rates

  1, 6, 12 months and annually up to 36 months

• Cardiac death rates

  1, 6, 12 months and annually up to 36 months

• All-cause mortality rates

  1, 6, 12 months and annually up to 36 months

• Target vessel myocardial infarction rates

  1, 6, 12 months and annually up to 36 months

• Definite and probable scaffold thrombosis rates

  1, 6, 12 months and annually up to 36 months

Study Arms (2)

Resorbable magnesium scaffold

ACTIVE COMPARATOR

3rd generation resorbable magnesium scaffolds

Device: Percutaneous coronary intervention

Drug eluting stent

ACTIVE COMPARATOR

Biodegradable polymer drug eluting stents

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

Percutaneous coronary intervention with scaffold implantation in patients with NSTE/ACS

Drug eluting stent; Resorbable magnesium scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years old.
• Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
• Patient has given written consent to participate in the trial.
• Patients presenting with NSTE/ACS documented in an emergency department or cath lab fulfilling the NSTE/ACS definition of the ESC guidelines (18, 20).
• Patients undergoing PCI for the index NSTE/ACS.
• Reference index vessel diameter between 2.5-4.2 mm and length ≤28mm by visual estimation.
• Lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and Thrombolysis in Myocardial Infarction (TIMI) flow \>2 and residual stenosis \<20%.
• Culprit lesion treatment only in the index procedure with planned implantation of one only RMS.
• Patients who have no contraindication for.dual antiplatelet therapy (DAPT).

You may not qualify if:

• A known hypersensitivity or contraindication to any of the following: aspirin, heparin, ticagrelor, prasugrel, bivalirudin, clopidogrel, scaffold material, contrast media, sirolimus.
• Ongoing infection, including active endocarditis.
• NSTE/ACS due to in stent/scaffold thrombosis/restenosis.
• Culprit vessel left main.
• Ostial target lesion (within 5.0 mm of vessel origin).
• Bifurcation target lesions Medina 1,1,1 with upfront planned 2-stent technique.
• Bifurcation side branch target lesions Medina 0,0,1.
• Known thrombocytopenia (PLT\<100,000/mm3).
• 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).
• Culprit lesion requiring preparation with technique other than semi/non-compliant and/or cutting/scoring balloons (eg rotational/orbital atherectomy, shockwave lithotripsy).
• Planned PCI in more lesions than the culprit one at the index procedure.
• Culprit vessel located or supplied by bypass graft.
• Life expectancy less than 1 year.
• Active severe bleeding (Bleeding Academic Research Consortium classification ≥III) (21).
• Cardiogenic shock.

Sponsors & Collaborators

• Konstantinos Toutouzas: lead
• Centre Hospitalier Universitaire Saint Pierre: collaborator
• Université Catholique de Louvain: collaborator
• University Hospital of Leuven Leuven: collaborator
• University of Patras: collaborator
• Ippokrateio General Hospital of Thessaloniki: collaborator

Study Sites (7)

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

UC Louvain

Leuven, Belgium

Location

Hippocration Hospital

Athens, Attica, 11527, Greece

Location

Hippokration hospital

Thessaloniki, Greece

Location

Geneva University Hospitals

Geneva, Switzerland

Location

Related Publications (6)

• 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: 37334655 RESULT

• Verheye S, Wlodarczak A, Montorsi P, Torzewski J, Bennett J, Haude M, Starmer G, Buck T, Wiemer M, Nuruddin AAB, Yan BP, Lee MK. BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):E1-E8. doi: 10.1002/ccd.29260. Epub 2020 Sep 3.

  PMID: 32881396 RESULT

• de Hemptinne Q, Xaplanteris P, Guedes A, Demeure F, Vandeloo B, Dugauquier C, Picard F, Warne DW, Pilgrim T, Iglesias JF, Bennett J. Magmaris Resorbable Magnesium Scaffold Versus Conventional Drug-Eluting Stent in ST-Segment Elevation Myocardial Infarction: 1-Year Results of a Propensity-Score-Matching Comparison. Cardiovasc Revasc Med. 2022 Oct;43:28-35. doi: 10.1016/j.carrev.2022.05.028. Epub 2022 May 26.

  PMID: 35641364 RESULT

• Koliastasis L, Bennett J, Xaplanteris P, Skalidis I, Guedes A, Demeure F, Vandeloo B, Dugauquier C, Picard F, Warne DW, Pilgrim T, Iglesias JF, de Hemptinne Q. Two-year clinical outcomes of resorbable magnesium scaffold versus conventional drug-eluting stents in ST-segment elevation myocardial infarction: A propensity score matching analysis. Hellenic J Cardiol. 2024 Jul-Aug;78:84-86. doi: 10.1016/j.hjc.2023.12.004. Epub 2023 Dec 21. No abstract available.

  PMID: 38134970 RESULT

• Sabate M, Alfonso F, Cequier A, Romani S, Bordes P, Serra A, Iniguez A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Cuesta J, Gomez-Hospital JA, Ortega-Paz L, Gomez-Lara J, Brugaletta S. Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1904-1916. doi: 10.1161/CIRCULATIONAHA.119.043467. Epub 2019 Sep 25.

  PMID: 31553204 RESULT

• Fajadet J, Haude M, Joner M, Koolen J, Lee M, Tolg R, Waksman R. Magmaris preliminary recommendation upon commercial launch: a consensus from the expert panel on 14 April 2016. EuroIntervention. 2016 Sep 18;12(7):828-33. doi: 10.4244/EIJV12I7A137.

  PMID: 27639734 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Leonidas Koliastasis, MD, PhD

  National and Kapodistrian University of Athens, CHU Saint-Pierre

  STUDY DIRECTOR

• Konstantinos Toutouzas, Professor

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Quentin de Hemptinne, Professor

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonidas Koliastasis, MD, PhD

CONTACT

6974270752; lkoliastasis@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Cardiology

Model Details: 3rd generation resorbable magnesium scaffolds "Freesolve" will be compared to the biodegradable polymer drug eluting stents "Orsiro" in patients with NSTE/ACS

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); BE (4); GR (2)