Clinical trial NCT04483791: DynamX Bioadaptor Hong Kong Registry
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: drug eluting stent
percutaneous coronary intervention
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, multicenter registry
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Acute Device Success
timeFrame: Immediately after final stent placement (intraprocedure)
measure: Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).
timeFrame: 12 Months
Secondary outcomes:
measure: Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).
timeFrame: 1 month
measure: Number of Participants With Cardiovascular and Non-Cardiovascular Death
timeFrame: 1 month
measure: Number of Participants With Cardiovascular and Non-Cardiovascular Death
timeFrame: 6 months
measure: Number of Participants With Cardiovascular and Non-Cardiovascular Death
timeFrame: 12 months
measure: Number of Participants With Myocardial Infarction
timeFrame: 1 month
measure: Number of Participants With Myocardial Infarction
timeFrame: 6 months
measure: Number of Participants With Myocardial Infarction
timeFrame: 12 months
measure: Number of Participants With Clinically-Indicated Target Lesion Revascularization
timeFrame: 1 month
measure: Number of Participants With Clinically-Indicated Target Lesion Revascularization
timeFrame: 6 month
measure: Number of Participants With Clinically-Indicated Target Lesion Revascularization
timeFrame: 12 month
measure: Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Kwong Wah Hospital
state: Kowloon
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
state: Kowloon
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Pok Fu Lam
city: Hong Kong
country: China
facility: Chinese University of Hong Kong / Prince of Wales Hospital
state: Sha Tin
Study officials:
References: