Trial document




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  DRKS00006144

Trial Description

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Title

A POST-MARKET EVALUATION OF THE CE MARK APPROVED DESolve® NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS

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Trial Acronym

DESolve PMCF Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To evaluate the safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System in patients with narrowing coronary blood vessels

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Brief Summary in Scientific Language

To evaluate the safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

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Organizational Data

  •   DRKS00006144
  •   2014/05/12
  •   2013/12/06
  •   no
  •   Approved
  •   292/13, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  •   NCT02013349  (Clinicaltrials.gov)
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Health Condition or Problem studied

  •   I25 -  Chronic ischaemic heart disease
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Interventions/Observational Groups

  •   DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) - CI-MACE is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization) at 1, 6 months and 1, 2, 3, 4, 5 years

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Secondary Outcome

Acute success (device success and procedure success assessed for the target lesion/vessel procedure)

Clinically-Indicated Target Lesion Revascularization (CI-TLR) at 1, 6 months and 1, 2, 3, 4, 5 years

Clinically-Indicated Target Vessel Revascularization (CI-TVR) at 1, 6 months and 1, 2, 3, 4, 5 years

All Myocardial Infarction (MI) occuring after Implatation untill 5 year Follow Up

Scaffold thrombosis at 1, 6 months and 1, 2, 3, 4, 5 years*

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Countries of Recruitment

  •   Italy
  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/03/24
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion 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 DESolve NE BCSS 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
6. Patient must agree not to participate in any other clinical study for a period of two years following the index procedure

Angiographic Inclusion Criteria
Target lesion must be located in a native coronary artery with a nominal vessel diameter of between 2.75 and 3.5 mm assessed by visual estimation or QCA
1. Target lesion must measure ≤ 24 mm in length
2. Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 90% with a TIMI flow of ≥ 1
3. Percutaneous intervention of lesions in the target vessel if:
a) Not part of a clinical investigation
b) ≥ 6 months prior to the study index procedure
c) ≥ 9 months after the study index procedure (planned)
d) Previous intervention was distal to and > 10 mm from the target lesion
4. Percutaneous intervention of lesions in a non-target vessel if:
a) Not part of a another clinical investigation
b) ≥ 30 days prior to the study index procedure
c) ≥ 9 months after the study index procedure (planned)

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Exclusion Criteria

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 has a known left ventricular ejection fraction (LVEF) < 30%
6. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
7. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
8. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus)
9. Patient is receiving chronic anticoagulation therapy (e.g., heparin, Coumadin) that cannot be stopped and restarted according to local hospital standard procedures
10. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Novolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
11. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
12. 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
13. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
14. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
15. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
16. Patient has had a significant GI or urinary bleed within the past six months
17. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
18. 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)
19. Patient is already participating in another clinical study
20. 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
21. 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:
a. Aorto-ostial location
b. Left main location
c. Located within 5 mm of the origin of the LAD or LCX
d. Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
e. Lesion involving a side branch >2mm in diameter or bifurcation
f. Previous placement of a scaffold proximal to or within 10 mm of the target lesion
g. Total occlusion (TIMI flow 0), or sub-total occlusion (TIMI flow 1)
h. Excessive tortuosity proximal to or within the lesion
i. Angulation (≥ 45o) proximal to or within the lesion
j. Calcification moderate or heavy
k. 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
4. Patient has a high probability that a procedure other than pre-dilatation and scaffolding 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 or brachytherapy)

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Addresses

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    • Elixir Medical Corporation
    • Ms.  Stephanie   S. Plaumann 
    • 920 N McCarthy Blvd, Suite 100
    • 93035  Milpitas
    • United States
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    • Elixir Medical Corporation
    • Ms.  Stephanie  S. Plaumann 
    • 920 N Mc Carthy Blvd. Suite 100
    • 95035  Milpitas
    • United States
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    • Elixir Medical Corporation
    • Ms.  Sara  Toyloy 
    • 920 N Mc Carthy Blvd. Suite 100
    • 95035  Milpitas
    • United States
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Sources of Monetary or Material Support

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    • Elixir Medical Corporation
    • 920 N Mc Carthy Blvd. Suite 100
    • 95035  Milpitas
    • United States
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    •   +1-408-636-2000
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/30
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Trial Publications, Results and other Documents

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