DynamX Bioadaptor Hong Kong Registry

NCT04483791 | Completed Phase 4 Results

• 1 other identifier: ELX-CL-2001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

Prospective, non-randomized, multicenter registry

Conditions

Coronary Artery Disease

Keywords

drug eluting stent; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• 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

  Immediately after final stent placement (intraprocedure)

• Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).

  the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization

  12 Months

Secondary Outcomes (11)

• Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).

  1 month

• Number of Participants With Cardiovascular and Non-Cardiovascular Death

  1 month

• Number of Participants With Cardiovascular and Non-Cardiovascular Death

  6 months

• Number of Participants With Cardiovascular and Non-Cardiovascular Death

  12 months

• Number of Participants With Myocardial Infarction

  1 month

Study Arms (1)

DynamX Novolimus Eluting Coronary Bioadaptor System

OTHER

DynamX use in de novo coronary artery lesions

Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System

Interventions

DynamX Novolimus Eluting Coronary Bioadaptor System 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

Also known as: Novolimus, Bioadaptor

DynamX Novolimus Eluting Coronary Bioadaptor System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age ≥ 18 and ≤ 80 years
• Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
• 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)
• Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion
• All lesions requiring PCI should be amendable for implantation with the study stent
• 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%

You may not qualify if:

• Target lesion / vessel specific
• Lesions in the left main
• Venous or arterial bypass grafts
• In-stent restenosis
• Chronic total occlusion
• Ostial lesions (\< 3 mm from the ostium of the RCA, LAD or Cx)
• Stent implanted \< 10 mm from the target lesion in the previous 30 days.
• Lesion requiring rotablation or atherectomy because of, but not limited to severe calcification
• Bifurcation lesions requiring a planned 2 or more stent technique
• Patient specific:
• STEMI
• Acute myocardial infarction with Killip Class III and IV
• Known LVEF \< 30%
• Life expectancy \< 1 year
• Patients on renal dialysis or known GFR \< 30 ml/min

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (4)

Kwong Wah Hospital

Hong Kong, Kowloon, China

Location

Queen Elizabeth Hospital

Hong Kong, Kowloon, China

Location

Queen Mary Hospital

Hong Kong, Pok Fu Lam, China

Location

Chinese University of Hong Kong / Prince of Wales Hospital

Hong Kong, Sha Tin, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

novolimus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Candace Elek, M.S.
• Organization: EVP, Clinical Research

celek@elixirmedical.com

408-913-5468

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, multicenter registry

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 23, 2020
• Study Start: September 30, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)