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Completed

NCT Number: NCT05464147

DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DynamX Drug-Eluting Coronary Bioadaptor System

Device

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

Primary outcomes

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

    Time frame: Through 9 months

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

Secondary outcomes

  1. Major Adverse Cardiac Event (MACE)

    Time frame: 9 months, 12 months and 24 months

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

  2. Cardiac Death (CD)

    Time frame: 9 months, 12 months and 24 months

    Cardiac Death (CD)

  3. Myocardial Infarction (MI)

    Time frame: 9 months, 12 months and 24 months

    Myocardial Infarction (MI)

  4. Target Lesion Revascularization (TLR)

    Time frame: 9 months, 12 months and 24 months

    Target Lesion Revascularization (TLR)

  5. Stent Thrombosis (ST)

    Time frame: 9 months, 12 months and 24 months

    Stent Thrombosis (ST)

  6. Stent Cross-Sectional Area

    Time frame: 9 months

    Stent Cross-Sectional Area by OCT

  7. Minimum stent diameter

    Time frame: 9 months

    Minimum stent diameter by OCT

  8. Maximum stent diameter

    Time frame: 9 months

    Maximum stent diameter by OCT

  9. Intimal hyperplasia (IH) area

    Time frame: 9 months

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

  10. Percentage of intimal hyperplasia

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

Elixir Medical Corporation

Industry

Collaborators

  • Istituto Clinico Humanitas

Registry information

Official study title

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

Acronym: DYNAMITE

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 19, 2022
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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