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
Phase: PHASE4
Conditions: Coronary Artery Disease
Sponsor: Elixir Medical Corporation

 
 
DynamX Bioadaptor Hong Kong Registry  
NCT04483791 
 
 
 
Study Title: DynamX Bioadaptor Hong Kong Registry 
NCT Number: NCT04483791 
Protocol Number: ELX-CL-2001 
Version 2.0, 7 December 2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Confidential – This document is property of Elixir Medical Corporation 
 

 
 
DynamX Bioadaptor Hong Kong Registry  
NCT04483791 
 
 
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  
“DynamX Hong Kong Registry” 
Objective 
To confirm the clinical performance of the DynamX™ Novolimus Eluting 
Coronary Bioadaptor System with regard to acute device success defined 
as a < 30% residual stenosis of the target site using the assigned device 
without the need for other non-study stents or adjunctive devices (e.g. 
rotablator or atherectomy) and to collect longer-term clinical data at 1, 6 
and 12 Months.  
Study design 
A prospective, non-randomized, multicenter registry. 
 
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 clinic visit at 1 month. Follow-up 
will continue at 6, and 12 months. to capture cardiovascular related 
hospitalizations related to the study device.  
 
 
 
Enrollment/ 
Number of Sites 
Enrollment of up to 50 subjects at approximately four centers in Hong 
Kong  
Study Devices 
DynamX® Novolimus Eluting Coronary Bioadaptor System 
  
Key 
Endpoints:   
 
Performance:  
Acute Device Success: attainment of final result of < 30% residual stenosis 
using the DynamX bioadaptor with standard pre-dilatation and post-
dilatation (if applicable) catheters  
Clinical parameters to be evaluated  
• Device Oriented Clinical Endpoint (DOCE) at 1, 6, and 12 Months, 
defined as the composite of cardiovascular death, target vessel myocardial 
infarction (TV-MI)*, or clinically-driven target lesion revascularization 
(ID-TLR).  
• Death at 1, 6 and 12 Months; Cardiac and non-cardiac  
• Myocardial infarction at 1, 6 and 12 Months  
• Clinically-indicated Target Lesion and Target Vessel Revascularization 
(TLR and TVR) at 1, 6 and 12 Months  
• Device Thrombosis at 1, 6 and 12 Months  
 
Endpoints will be defined as per the Academic Research Consortium (ARC-
2) criteria  

 
 
DynamX Bioadaptor Hong Kong Registry  
NCT04483791 
 
 
 
Key Inclusion 
Criteria 
 
Candidates for this study must meet all of the following 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 to 0.5 mm smaller than the reference vessel diameter, and a 
residual diameter stenosis prior to study device implantation by visual 
estimate being < 35%  
 
Key Exclusion 
Criteria 
 
Candidates will be ineligible for enrollment in the study if any of the 
following conditions apply:  
1. Target lesion / vessel specific 
a. Lesions in the left main  
b. Venous or arterial bypass grafts  
c. In-stent restenosis  
d. Chronic total occlusion  
e. Ostial lesions (< 3 mm from the ostium of the RCA, LAD or 
Cx)  
f. Stent implanted < 10 mm from the target lesion in the previous 
30 days  
g. Lesion requiring rotablation or atherectomy because of, but not 
limited to, severe calcification  
h. Bifurcation lesions requiring a planned 2 or more stent 
technique  
 
2. Patient specific: 
a. STEMI  
b. Acute myocardial infarction with Killip Class III and IV  
c. Known LVEF < 30%  
d. Life expectancy < 1 year  
e. Patients on renal dialysis or known GFR < 30 ml/min.  
 

 
 
DynamX Bioadaptor Hong Kong Registry  
NCT04483791 
 
 
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  
 
Statistical 
Analysis 
This registry was designed to confirm the performance of the 
DynamX Novolimus Eluting Coronary Bioadaptor System with 
regards to the residual risks of lesion access and acute device 
implantation through visually-assessed angiographic endpoints and 
physician feedback and demonstrate that these characteristics are 
acceptable. 
Data for all categorical endpoints was summarized with patient counts 
and percentages. 
While this registry is not powered to determine rare events, the 
sample size is sufficient to determine device related performance 
issues. 
Observational comparisons were provided from the DynamX 
Mechanistic study. 
Sponsor 
Elixir Medical Corporation 
920 N McCarthy Blvd, Suite 100  
Milpitas, CA 95035 
USA