EXCELLA Post-Approval Study

NCT02009956 | Completed

• 1 other identifier: ELX-CL-1004
• Study Type: interventional
• Target: 57
• Locations: 3 countries
• Sites: 4

Brief Summary

To evaluate long-term safety and performance of the DESyne Novolimus Eluting Coronary Stent System and the DESyne BD Novolimus Eluting Coronary Stent System

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Device-oriented Composite Endpoint (DoCE)

  Device-oriented Composite Endpoint (DoCE) at 1, 9, 12, and 24 months. DoCE is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.

  1, 9, 12, and 24 months

Study Arms (1)

DESyne Novolimus Eluting CSS

OTHER

Enrollment of up to 50 patients with up to two de novo native coronary artery lesions measuring between 2.5 and 4.0 mm in diameter and \</= 34 mm in length receiving the DESyne Novolimus Eluting CSS.

Device: Subjects receiving DESyne Novolimus Eluting CSS

Interventions

Subjects receiving DESyne Novolimus Eluting CSS DEVICE

DESyne Novolimus Eluting CSS

Eligibility Criteria

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

You may qualify if:

• The patient must be ≥18 years of age.
• The patient must have angina pectoris as defined by the Canadian Cardiovascular Society Classification, documented silent ischemia, or a positive functional study.
• The patient has a planned intervention of up to two lesions each coverable by a single stent located in separate major epicardial territories. Each lesion/vessel must meet the following criteria:
• De novo lesion
• The target lesion reference site must be visually estimated to be ≥ 2.5 mm and ≤ 4.0 mm in diameter.
• The target vessel must be a major coronary artery or major branch with a visually estimated stenosis of ≥ 50% and \<100%.
• The visually estimated target lesion length must be ≤ 34 mm (DESyne Novolimus Eluting CSS) (Arm A)\*.
• The visually estimated target lesion length must be ≤ 34 mm (DESyne BD Novolimus Eluting CSS) (Arm B)\*
• ≥ TIMI 1 coronary flow.
• \*Subject to commercial availability of product sizes in the specific region/country.
• The patient must be an acceptable candidate for coronary artery bypass surgery.
• Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure and must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.
• The patient and the patient's physician agree to the follow-up schedule.
• The patient or guardian who has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

You may not qualify if:

• The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated.
• The patient is a female, intending to get pregnant within the next year.
• Target vessel(s) require a staged procedure post index hospitalization discharge through 9 months of this index procedure.
• There will be an untreated significant lesion of \> 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.
• Previous placement of a stent within 10 mm of the target lesion.
• Total occlusion or TIMI 0 coronary flow in the target vessel.
• Restenosis lesion
• The proximal target vessel or target lesion is severely calcified by visual assessment.
• Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
• Lesion involvement of a significant side branch (branch diameter \> 2 mm) that would be covered by stenting.
• High probability that treatment other than PTCA or stenting will be required for treatment of the same lesion.
• The patient has suffered a myocardial infarction within the past 72 hours and the CK or CK-MB has not returned to normal at the time of the index procedure.
• The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past six months.
• The patient has renal insufficiency as determined by a creatinine of \> 2.0 mg/dl.

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (4)

Krankenhaus der Barmherzigen Brüder

Trier, 54292, Germany

Location

Jordan Hospital

Amman, 11152, Jordan

Location

King Abdullah University Hospital

Irbid, 22110, Jordan

Location

Santiago de Compostela University Hospital Complex

Santiago de Compostela, 15706, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

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: December 6, 2013
• First Posted: December 12, 2013
• Study Start: February 26, 2014
• Primary Completion: March 2, 2015
• Study Completion: June 1, 2016
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

JO (2); ES (1); DE (1)