DynamX Bioadaptor Hong Kong Registry

NCT ID: NCT04483791

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-12-31

Brief Summary

Prospective, non-randomized, multicenter registry

Detailed 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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

DynamX Novolimus Eluting Coronary Bioadaptor System

DynamX use in de novo coronary artery lesions

Group Type: OTHER

DynamX Novolimus Eluting Coronary Bioadaptor System

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Novolimus; Bioadaptor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elixir Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kwong Wah Hospital

Hong Kong, Kowloon, China

Queen Elizabeth Hospital

Hong Kong, Kowloon, China

Queen Mary Hospital

Hong Kong, Pok Fu Lam, China

Chinese University of Hong Kong / Prince of Wales Hospital

Hong Kong, Sha Tin, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

ELX-CL-2001

Identifier Type: -

Identifier Source: org_study_id