Evaluation of a Thin Strut Metallic Stent: the Elixir DynamX Clinical Study

NCT03429894 | Completed

• 1 other identifier: ELX-CL-1704
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief Summary

The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at 30 days, 6 and 9 months, and 1, 2 and 3 years. All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (5)

• Target Lesion Failure (TLF)

  Target Lesion Failure (composite of cardiac death, target vessel MI, and clinically-indicated target lesion revascularization)

  6 months

• Change in Mean In-Device Area compared to post-procedure as measured by IVUS

  9 or 12 months

• Change in Mean Lumen Area compared to post-procedure as measured by IVUS

  9 or 12 months

• Late Lumen Loss (LLL) as measured by QCA

  9 or 12 months

• Late Lumen Loss (LLL) as measured by IVUS

  9 or 12 months

Secondary Outcomes (15)

• Device Success

  During Procedure

• Procedure Success

  In Hospital through Discharge

• Target Lesion Failure (TLF)

  30 days, 1, 2 and 3 years

• Cardiac Death

  30 days, 180 days, 1, 2 and 3 years

• Non-Cardiac Death

  30 days, 180 days, 1, 2 and 3 years

Other Outcomes (13)

• Acute Recoil

  During Procedure

• Minimum Lumen Diameter (MLD)

  During Procedure

• % Diameter Stenosis (DS)

  During Procedure

Study Arms (1)

Treatment

EXPERIMENTAL

All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months.

Device: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention DEVICE

Drug eluting stent implant

Treatment

Eligibility Criteria

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

You may qualify if:

• Patient must be at least 18 years of age.
• Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DynamX Novolimus Eluting Coronary Stent System (CSS) and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure.
• Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)
• Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
• Patient must agree to undergo all clinical study required follow-up visits, angiograms, and IVUS testing
• Patient must agree not to participate in any other clinical study for a period of one year following the index procedure.
• Target lesion must be located in a native coronary artery with a nominal vessel diameter of ≥ 2.5 and ≤3.5 mm assessed visually or by online QCA
• Target lesion must measure ≤ 24 mm in length
• Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 90% with a TIMI flow of ≥ 2
• The lesion must be successfully pre-dilated (less than 35% DS) prior to enrollment
• \. Treatment of a single, non-target lesion located in a separate major epicardial vessel (defined as LAD with septal and diagonal branches, LCX with obtuse marginal and/or ramus intermedius branches and RCA and any of its branches) attempted during the index procedure must be completed first using an approved 'olimus drug eluting stent. The segment must be located such that any injury that might occur during intervention can be clearly attributable to the treated non-target vessel. If the procedure is deemed uncomplicated and optimal, treatment of the target lesion with the DynamX stent can be considered.
• Optimal lesion/vessel treatment defined as:
• \< 10% but no more than 15% residual diameter stenosis by visual assessment
• no evidence of dissection
• no evidence of thrombus in the treated lesion or vessel

You may not qualify if:

• Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
• Patient is currently experiencing clinical symptoms consistent with AMI
• Patient requires the use of any rotablator intervention during the index procedure
• Patient has current unstable arrhythmias
• Patient presenting with heart failure, chronic arrhythmia, COPD or lung function impairment
• Patient has a known left ventricular ejection fraction (LVEF) \< 30%
• Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
• Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
• Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
• Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures.
• Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Novolimus, CoCr alloys, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
• Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors.
• Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease.
• Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (2)

AZ Middelheim Hospital

Antwerp, 2020, Belgium

Location

Ospendale San Raffaele

Milan, 20132, Italy

Location

Related Publications (1)

• Verheye S, Vrolix M, Montorfano M, Giannini F, Bedogni F, Dubois C, De Bruyne B, Costa RA, Chamie D, Costa JR Jr, Abizaid A, Colombo A. Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data. Rev Cardiovasc Med. 2023 Aug 1;24(8):221. doi: 10.31083/j.rcm2408221. eCollection 2023 Aug.

  PMID: 39076703 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Stefan Verheye, MD

  ZNA Middelheim

  PRINCIPAL INVESTIGATOR

• Antonio Colombo, MD

  San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 12, 2018
• Study Start: November 16, 2017
• Primary Completion: September 17, 2019
• Study Completion: December 31, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

BE (1); IT (1)