DynamX Bioadaptor Hong Kong Registry

Coronary Artery Disease Clinical Trial

Official title:

A Non-Randomized, Clinical Registry of the Dynamx Novolimus Eluting Coronary Bioadaptor System in the Treatment of Patients With De Novo Native Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483791
• Other study ID #: ELX-CL-2001
• Status: Completed
• Phase: Phase 4
• Start date: September 30, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Elixir Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, non-randomized, multicenter registry

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Combination Product:
• DynamX Novolimus Eluting Coronary Bioadaptor System
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

Locations

Country	Name	City	State
China	Chinese University of Hong Kong / Prince of Wales Hospital	Hong Kong	Sha Tin
China	Kwong Wah Hospital	Hong Kong	Kowloon
China	Queen Elizabeth Hospital	Hong Kong	Kowloon
China	Queen Mary Hospital	Hong Kong	Pok Fu Lam

Sponsors (1)

Lead Sponsor	Collaborator
Elixir Medical Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Device Success	Percentage of patients with an attainment of a final result of < 30% residual stenosis using the DynamX bioadaptor with standard pre-dilatation and post-dilatation (if applicable) catheters	procedure
Primary	Device Oriented Clinical Endpoint	the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization	6 months
Secondary	Device Oriented Clinical Endpoint	the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization	1 month
Secondary	Device Oriented Clinical Endpoint	the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization	12 months
Secondary	death	cardiac and non-cardiac	1 month
Secondary	death	cardiac and non-cardiac	6 months
Secondary	death	cardiac and non-cardiac	12 months
Secondary	myocardial infarction	target vessel and non-target vessel	1 month
Secondary	myocardial infarction	target vessel and non-target vessel	6 months
Secondary	myocardial infarction	target vessel and non-target vessel	12 months
Secondary	target lesion revascularization	clinically-indicated	1 month
Secondary	target lesion revascularization	clinically-indicated	6 month
Secondary	target lesion revascularization	clinically-indicated	12 month