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Trial record 1 of 2 for:    verheye, bioadaptor | Coronary Artery Disease
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Evaluation of a Thin Strut Metallic Stent: the Elixir DynamX Clinical Study

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ClinicalTrials.gov Identifier: NCT03429894
Recruitment Status : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Elixir Medical Corporation

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Percutaneous Coronary Intervention Not Applicable

Detailed Description:

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.

At select centers, a subset of approximately 20 patients will undergo FFR pressure wire measurement at baseline and at follow-up (or at a minimum follow-up) in conjunction with the IVUS imaging, and will also undergo OCT imaging at 9 or 12 months.

The primary safety endpoint is Target Lesion Failure at 6 months. TLF is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization.

The primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is the change in mean in-device area and mean lumen area at 9 or 12 months compared to post-procedure as measured by IVUS.

Co-primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is late lumen loss as measured by QCA and IVUS at 9 or 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Thin Strut Metallic Stent: the Elixir DynamXTM Novolimus Eluting Coronary Bioadaptor System
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : September 17, 2019
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Treatment
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
Drug eluting stent implant




Primary Outcome Measures :
  1. Target Lesion Failure (TLF) [ Time Frame: 6 months ]
    Target Lesion Failure (composite of cardiac death, target vessel MI, and clinically-indicated target lesion revascularization)

  2. Change in Mean In-Device Area compared to post-procedure as measured by IVUS [ Time Frame: 9 or 12 months ]
  3. Change in Mean Lumen Area compared to post-procedure as measured by IVUS [ Time Frame: 9 or 12 months ]
  4. Late Lumen Loss (LLL) as measured by QCA [ Time Frame: 9 or 12 months ]
  5. Late Lumen Loss (LLL) as measured by IVUS [ Time Frame: 9 or 12 months ]

Secondary Outcome Measures :
  1. Device Success [ Time Frame: During Procedure ]
    Successful delivery of the device and a final residual stenosis < 30% by QCA

  2. Procedure Success [ Time Frame: In Hospital through Discharge ]
    Successful delivery of the device and a final residual stenosis < 30% by QCA without TLF through hospital discharge

  3. Target Lesion Failure (TLF) [ Time Frame: 30 days, 1, 2 and 3 years ]
    Target Lesion Failure (composite of cardiac death, target vessel MI, and clinically-indicated target lesion revascularization)

  4. Cardiac Death [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Cardiac Death

  5. Non-Cardiac Death [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Non-Cardiac death

  6. Q-wave Myocardial Infarction (Q-MI) [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Q-MI

  7. Non-Q-wave Myocardial Infarction (NQ-MI) [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    NQ-MI

  8. Target Vessel Myocardial Infarction (TV-MI) [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Target Vessel MI

  9. Non-Target Vessel Myocardial Infarction (NTV-MI) [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Non-Target Vessel MI

  10. Clinically-Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    CI-TLR

  11. Non-Clinically Indicated Target Lesion Revascularization (Non-CI-TLR) [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Non-CI-TLR

  12. Clinically Indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    CI-TVR

  13. Non-Clinically Indicated Target Vessel Revascularization [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Non-CI-TVR

  14. Target Vessel Failure (TVF) [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Composite of cardiac death, target vessel MI, clinically indicated target vessel revascularization

  15. Stent Thrombosis [ Time Frame: 30 days, 180 days, 1, 2 and 3 years ]
    Definite & Probable Stent Thrombosis (per ARC)


Other Outcome Measures:
  1. Acute Recoil [ Time Frame: During Procedure ]
    Acute Recoil by QCA

  2. Minimum Lumen Diameter (MLD) [ Time Frame: During Procedure ]
    MLD by QCA

  3. % Diameter Stenosis (DS) [ Time Frame: During Procedure ]
    % DS by QCA

  4. Late Lumen Loss (LLL) [ Time Frame: 9 months ]
    Late lumen loss (in-stent and in-segment) by QCA

  5. Change in mean and minimum lumen, stent and vessel areas from post-procedure [ Time Frame: 9 or 12 months ]
    Change in mean lumen are, device area and vessel area by IVUS

  6. In-stent % neointimal obstruction [ Time Frame: 9 or 12 months ]
    In-stent % neointimal obstruction by IVUS

  7. In-stent late lumen loss (LLL) [ Time Frame: 9 or 12 months ]
    In-stent late lumen loss (LLL) byIVUS

  8. Vasomotion (Pulsatility) [ Time Frame: 9 or 12 months ]
    Vasomotion (Pulsatility) assessment at during systole and diastole by IVUS

  9. Stent malapposition [ Time Frame: During procedure, 9 or 12 months ]
    Acute, persistent and late stent malapposition by IVUS

  10. Fractional Flow Reserve (FFR) [ Time Frame: During procedure, 9 or 12 months ]
    FFR measurements in the treated vessel

  11. Assessment of disengagement segments [ Time Frame: 9 or 12 months ]
    Assessment of disengagement segments by OCT

  12. Incomplete scaffold/device apposition [ Time Frame: 9 or 12 months ]
    Incomplete scaffold/device apposition by OCT

  13. Scaffold/Device Area and Lumen Area [ Time Frame: 9 or 12 months ]
    Scaffold/Device Area and Lumen Area on OCT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Patient must be at least 18 years of age.
  2. 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.
  3. 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)
  4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  5. Patient must agree to undergo all clinical study required follow-up visits, angiograms, and IVUS testing
  6. Patient must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria - Target Lesion/Vessel

  1. 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
  2. Target lesion must measure ≤ 24 mm in length
  3. 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
  4. The lesion must be successfully pre-dilated (less than 35% DS) prior to enrollment

Angiographic Inclusion Criteria - non-Target Lesion/Vessel Treatment

1. 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
  • TIMI 3 flow
  • Stent completely covers lesion and extends to healthy vessel on both sides (healthy to healthy)

General Exclusion Criteria

  1. 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
  2. Patient is currently experiencing clinical symptoms consistent with AMI
  3. Patient requires the use of any rotablator intervention during the index procedure
  4. Patient has current unstable arrhythmias
  5. Patient presenting with heart failure, chronic arrhythmia, COPD or lung function impairment
  6. Patient has a known left ventricular ejection fraction (LVEF) < 30%
  7. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  8. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
  9. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  10. Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures.
  11. 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
  12. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors.
  13. 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.
  14. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
  15. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  16. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  17. Patient has had a significant GI or urinary bleed within the past six months
  18. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
  19. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
  20. Patient is already participating in another clinical study which has not reached the primary endpoint (long-term follow-up is not an exclusion)
  21. Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
  22. Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority

Angiographic Exclusion Criteria

  1. Target lesion(s) meets any of the following criteria:

    1. Aorto-ostial location
    2. Left main location
    3. Tapering within target segment of 0.5mm or greater
    4. Located within 10 mm of the origin of the LAD or LCX
    5. Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
    6. Lesion involving a side branch >2mm in diameter or bifurcation
    7. Previous placement of a stent proximal to or within 10 mm of the target lesion
    8. Total or sub-total occlusion (TIMI flow ≤ 1)
    9. Excessive tortuosity or angulation (≥ 45o) proximal to or within the lesion
    10. The proximal target vessel or target lesion is moderately or severely calcified by visual assessment, or lesion prevents full pre-dilatation balloon expansion
    11. Previous intervention restenosis
  2. The target vessel contains visible thrombus
  3. Another clinically significant lesion (>40%) is located in the same major epicardial vessel as the target lesion (including side branches)
  4. Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon)
  5. Target vessel was previously treated with any type of PCI < 6 months prior to index procedure
  6. Non-Target vessel was previously treated with any type of PCI < 30 days prior to the index procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429894


Locations
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Belgium
AZ Middelheim Hospital
Antwerp, Belgium, 2020
Italy
Ospendale San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
Elixir Medical Corporation
Investigators
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Principal Investigator: Stefan Verheye, MD ZNA Middelheim
Principal Investigator: Antonio Colombo, MD San Raffaele Hospital
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Responsible Party: Elixir Medical Corporation
ClinicalTrials.gov Identifier: NCT03429894    
Other Study ID Numbers: ELX-CL-1704
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases