DESyne X2 Post Market Follow-up Study

NCT04375085 | Terminated Results FDA Device

• 1 other identifier: ELX-CL-1705
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

Brief Summary

A single-arm post-market clinical follow-up study to confirm that the DESyne X2 delivery system performs similarly to the DESyne delivery system.

Conditions

Coronary Artery Disease

Keywords

coronary stent; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Acute Success

  attainment of final result with \< 50% residual stenosis of the target site, using a DESyne X2 stent and standard pre-dilation catheters and post-dilatation catheters (if applicable)

  during procedure

Secondary Outcomes (1)

• Physician Assessment Was Performed After Each Case

  Post procedure

Study Arms (1)

DESyne X2 Novolimus Eluting Coronary Stent System

OTHER

Device: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention DEVICE

Percutaneous Coronary Intervention

DESyne X2 Novolimus Eluting Coronary Stent System

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 stable angina pectoris as defined by the Canadian Cardiovascular Society Classification, documented silent ischemia, acute coronary syndrome, or a positive functional study requiring treatment
• The patient is considered a candidate for coronary stent implantation and has a planned intervention of up to two lesions 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
• ≥ TIMI 1 coronary flow

You may not qualify if:

• The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor, heparin/bivalirudin, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated
• 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
• Previous placement of a stent within 10 mm distal to the target lesion
• Previous placement of a stent proximal to the target lesion
• Total occlusion or \< TIMI 1 coronary flow in the target vessel
• 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 left anterior descending or left circumflex
• 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 target lesion, or the target vessel proximal to the target lesion, contains thrombus
• 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 is a recipient of a heart transplant
• The patient has extensive peripheral vascular disease that precludes safe sheath insertion or extreme anti-coagulation
• The patient is currently participating in another investigational device or drug study that has not completed the primary follow-up phase
• Patients who are unable or unwilling to cooperate with study procedures

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (3)

Kwong Wah Hospital

Hong Kong, Kowloon, China

Location

Queen Elizabeth Hospital

Hong Kong, Kowloon, China

Location

Tseung Kwan O Hospital

Hong Kong, China

Location

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

Limitations and Caveats

The study was halted early with enrollment of 49 of the planned 100 patients due to slow enrollment.

Results Point of Contact

• Title: Candace Elek, EVP Clinical Research
• Organization: Elixir Medical Corp

celek@elixirmedical.com

4086362000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Prospective, non-randomized

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: September 1, 2020
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2023-10

Locations

CN (3)