DynamX Bioadaptor Hong Kong Registry

Elixir Medical

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04483791

ELX-CL-2001

Details and patient eligibility

About

Prospective, non-randomized, multicenter registry

Full description

Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture cardiovascular related hospitalizations related to the study devic

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject age ≥ 18 and ≤ 80 years
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
3. Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction)
4. Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion
5. All lesions requiring PCI should be amendable for implantation with the study stent
6. Successful pre-dilatation of the first lesion defined as no waist in the inflated pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the reference vessel diameter, and a residual diameter stenosis prior to study device implantation by visual estimate being < 35%

Exclusion criteria

1. Target lesion / vessel specific

   1. Lesions in the left main
   2. Venous or arterial bypass grafts
   3. In-stent restenosis
   4. Chronic total occlusion
   5. Ostial lesions (< 3 mm from the ostium of the RCA, LAD or Cx)
   6. Stent implanted < 10 mm from the target lesion in the previous 30 days.
   7. Lesion requiring rotablation or atherectomy because of, but not limited to severe calcification
   8. Bifurcation lesions requiring a planned 2 or more stent technique

2. Patient specific:

   1. STEMI
   2. Acute myocardial infarction with Killip Class III and IV
   3. Known LVEF < 30%
   4. Life expectancy < 1 year
   5. Patients on renal dialysis or known GFR < 30 ml/min

3. Planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months

4. Known intolerance to components of the investigational product or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy)

5. Subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin)

6. Subject is currently participating in another clinical trial with an investigational drug or device that has not yet completed its primary endpoint

7. Known pregnancy or breastfeeding

8. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

DynamX Novolimus Eluting Coronary Bioadaptor System

Other group

Description:

DynamX use in de novo coronary artery lesions

Treatment:

Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System