DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE)

DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE Study)

The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery; Multi Vessel Coronary Artery Disease; Bifurcation of Coronary Artery; Long Lesions Coronary Artery Disease
• Intervention / Treatment: Device: DynamX Drug-Eluting Coronary Bioadaptor System

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rozzano, Italy
    • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Presence of complex coronary lesions defined as follows:

• long lesions (>28 mm);
• CTO, a total occlusion of duration more than 3-months;
• Lesions involving a bifurcation, defined as a division with a side branch large enough to be stented (i.e. >2.25 mm);
• Patients requiring 4 or more stents
• Reference vessel diameter: >2.25 mm to <4.0 mm

Exclusion Criteria:

• Age under 18 years old;
• Significant co-morbidity precluding clinical follow-up;
• A positive pregnancy test in women with child-bearing potential;
• Contra-indication to dual anti-platelet therapy;
• Thrombocytopenia <100,000/uL;
• Major surgery planned which will lead to discontinuation of antiplatelet therapy;
• In-stent restenosis;
• Treatment of saphenous vein graft;
• CTO with long sub-intimal tracking (> 20 mm).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DynamX Drug-Eluting Coronary Bioadaptor System	Device: DynamX Drug-Eluting Coronary Bioadaptor System; DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean in-device lumen area and mean device area	Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT)	Through 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Event (MACE)	Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR])	9 months, 12 months and 24 months
Cardiac Death (CD)	Cardiac Death (CD)	9 months, 12 months and 24 months
Myocardial Infarction (MI)	Myocardial Infarction (MI)	9 months, 12 months and 24 months
Target Lesion Revascularization (TLR)	Target Lesion Revascularization (TLR)	9 months, 12 months and 24 months
Stent Thrombosis (ST)	Stent Thrombosis (ST)	9 months, 12 months and 24 months
Stent Cross-Sectional Area	Stent Cross-Sectional Area by OCT	9 months
Minimum stent diameter	Minimum stent diameter by OCT	9 months
Maximum stent diameter	Maximum stent diameter by OCT	9 months
Intimal hyperplasia (IH) area	Intimal hyperplasia (IH) area (calculated as stent area minus luminal area) by OCT	9 months
Percentage of intimal hyperplasia	Percentage of intimal hyperplasia (IH area divided by stent area) by OCT	9 months

Collaborators and Investigators

• Sponsor: Elixir Medical Corporation
• Collaborators: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 250521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes