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

E

Elixir Medical

Status

Active, not recruiting

Conditions

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

Treatments

Device: DynamX Drug-Eluting Coronary Bioadaptor System

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

DynamX Drug-Eluting Coronary Bioadaptor System
Experimental group
Treatment:
Device: DynamX Drug-Eluting Coronary Bioadaptor System

Trial contacts and locations

1

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Central trial contact

Antonio Colombo, MD

Data sourced from clinicaltrials.gov

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