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

Primary Purpose

Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery

Status

Active

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

DynamX Drug-Eluting Coronary Bioadaptor System

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Humanitas Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DynamX Drug-Eluting Coronary Bioadaptor System

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Major Adverse Cardiac Event (MACE)

Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR])

Cardiac Death (CD)

Myocardial Infarction (MI)

Target Lesion Revascularization (TLR)

Stent Thrombosis (ST)

Stent Cross-Sectional Area

Stent Cross-Sectional Area by OCT

Minimum stent diameter

Minimum stent diameter by OCT

Maximum stent diameter

Maximum stent diameter by OCT

Intimal hyperplasia (IH) area

Intimal hyperplasia (IH) area (calculated as stent area minus luminal area) by OCT

Percentage of intimal hyperplasia

Percentage of intimal hyperplasia (IH area divided by stent area) by OCT

Full Information

NCT ID

NCT05464147

First Posted

July 13, 2022

Last Updated

September 18, 2023

Sponsor

Elixir Medical Corporation

Collaborators

Istituto Clinico Humanitas

1. Study Identification

Unique Protocol Identification Number

NCT05464147

Brief Title

DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

Acronym

DYNAMITE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 19, 2021 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Elixir Medical Corporation

Collaborators

Istituto Clinico Humanitas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery, Multi Vessel Coronary Artery Disease, Long Lesions Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

All imaging analyses will be performed at an independent core laboratory (Cardiovascular Department, San Giovanni Addolorata Hospital, Rome, Italy) by experienced operators blinded to procedural data and clinical outcomes.

Allocation

N/A

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DynamX Drug-Eluting Coronary Bioadaptor System

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

DynamX Drug-Eluting Coronary Bioadaptor System

Intervention Description

DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion

Primary Outcome Measure Information:

Title

Change in mean in-device lumen area and mean device area

Description

Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT)

Time Frame

Through 9 months

Secondary Outcome Measure Information:

Title

Major Adverse Cardiac Event (MACE)

Description

Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR])

Time Frame