DynamX Bioadaptor Hong Kong Registry

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System

• Registration Number: NCT04483791
• Lead Sponsor: Elixir Medical Corporation

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

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-23
• Study Start: 2020-09-30
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Results First Submitted: 2024-09-17
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Results First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DynamX Novolimus Eluting Coronary Bioadaptor System	DynamX Novolimus Eluting Coronary Bioadaptor System	DynamX use in de novo coronary artery lesions

Primary Outcome Measures

Name	Time	Method
Acute Device Success	Immediately after final stent placement (intraprocedure)	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
Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).	12 Months	the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).	6 months	the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Number of Participants With Cardiovascular and Non-Cardiovascular Death	12 months	cardiac and non-cardiac
Number of Participants With Myocardial Infarction	12 months	target vessel and non-target vessel
Number of Participants With Clinically-Indicated Target Lesion Revascularization	12 month	clinically-indicated

Trial Locations

Locations (4)

Kwong Wah Hospital; 🇨🇳 Hong Kong, Kowloon, China

Queen Elizabeth Hospital; 🇨🇳 Hong Kong, Kowloon, China

Chinese University of Hong Kong / Prince of Wales Hospital; 🇨🇳 Hong Kong, Sha Tin, China

Queen Mary Hospital; 🇨🇳 Hong Kong, Pok Fu Lam, China