DynamX Bioadaptor Hong Kong Registry

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

Prospective, non-randomized, multicenter registry

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Combination product: DynamX Novolimus Eluting Coronary Bioadaptor System

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Kowloon
    • Hong Kong, Kowloon, China
      • Kwong Wah Hospital
    • Hong Kong, Kowloon, China
      • Queen Elizabeth Hospital
  • Pok Fu Lam
    • Hong Kong, Pok Fu Lam, China
      • Queen Mary Hospital
  • Sha Tin
    • Hong Kong, Sha Tin, China
      • Chinese University of Hong Kong / Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DynamX Novolimus Eluting Coronary Bioadaptor System; DynamX use in de novo coronary artery lesions	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; Other Names: Novolimus; Bioadaptor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month
Number of Participants With Cardiovascular and Non-Cardiovascular Death	cardiac and non-cardiac	1 month
Number of Participants With Cardiovascular and Non-Cardiovascular Death	cardiac and non-cardiac	6 months
Number of Participants With Cardiovascular and Non-Cardiovascular Death	cardiac and non-cardiac	12 months
Number of Participants With Myocardial Infarction	target vessel and non-target vessel	1 month
Number of Participants With Myocardial Infarction	target vessel and non-target vessel	6 months
Number of Participants With Myocardial Infarction	target vessel and non-target vessel	12 months
Number of Participants With Clinically-Indicated Target Lesion Revascularization	clinically-indicated	1 month
Number of Participants With Clinically-Indicated Target Lesion Revascularization	clinically-indicated	6 month
Number of Participants With Clinically-Indicated Target Lesion Revascularization	clinically-indicated	12 month
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	6 months

Collaborators and Investigators

• Sponsor: Elixir Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; drug eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ELX-CL-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes