Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)

NCT02317081 | Unknown DMC

• 1 other identifier: AXETIS FIM
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

Prospective, multicenter, single arm study, to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.

Conditions

Native Coronary Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• In-stent Late Lumen Loss (LLL) assessed by off-line QCA

  6 months after stent implantation

Secondary Outcomes (7)

• Acute Lumen gain

  Post intervention (1 hour)

• Acute area gain

  Post intervention (1 hour)

• Percent Acute device success

  1 day post intervention

• late lumen loss

  6 months after intervention

• maximal neointimal thickness

  6 months after intervention

Study Arms (1)

Axetis Inert Coronary Stents

EXPERIMENTAL

Axetis Inert Coronary Stents for de novo coronary lesion

Device: Axetis Inert Coronary Stents

Interventions

Axetis Inert Coronary Stents DEVICE

de novo coronary artery stenosis in native vessels

Axetis Inert Coronary Stents

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 85 years
• Evidence of myocardial ischemia without elevatedTroponin / cardiac biomarkers (e.g.
• stable or unstable angina, silent ischemia demonstrated by positive territorial functional study). NSTEMI patients are allowed, as long as Troponin is within the normal limits before the start of the procedure.
• The patient has a planned intervention of up to two de-novo lesions in two different vessels (previously untreated vessels)
• Lesion must have a visually estimated diameter stenosis of ≥50% and \<100%.
• Lesion length must be ≤ 28 mm
• RVD must be between 2.4 and 3.8 mm
• Written informed consent
• The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT control at 6 months

You may not qualify if:

• Evidence of ongoing acute myocardial infarction in ECG and or elevated cardiac biomarkers prior to procedure.
• LVEF \<30%
• Platelet count \<100,000 cells/mm3 or \>400,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• Known renal insufficiency (e.g., eGFR \<60 ml/kg/m2 or serum creatinine level of \>2.5 mg/dL, or subject on dialysis)
• History of bleeding diathesis or coagulopathy
• The patient is a recipient of a heart transplant
• Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticagrelor and ticlopidine) or stainless steel
• Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
• Target lesion in left main stem.
• Target lesion involves a side branch \> 2.0mm in diameter
• Aorto-ostial target lesion (within 3 mm of the aorta junction).
• Total occlusion or TIMI flow 1, prior to wire crossing
• The target vessel contains visible thrombus

Sponsors & Collaborators

• Axetis AG: lead

Study Sites (3)

AMC Amsterdam, Netherlands

Amsterdam, Netherlands

RECRUITING

Thoraxcentrum Twente, Medisch Spectrum

Enschede, Netherlands

RECRUITING

St. Antonius

Nieuwegein, Netherlands

RECRUITING

Study Officials

• Yvonne Teunissen, PhD

  Cardialysis BV

  STUDY DIRECTOR

• Mariann Gyöngyösi, Prof. MD

  University Hospital, Cardiology, Vienna, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvio Schaffner

CONTACT

axetis@gmx.ch

Study Design

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

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 15, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

NL (3)