Purpose

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subject is an eligible candidate for percutaneous coronary intervention (PCI);
  • Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
  • Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
  • Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the

Exclusion Criteria

.

- Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;

Exclusion Criteria:

- The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;

- The subject's target lesion(s) is located in the left main artery;

- The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate;

- The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;

- The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Svelte
  • Device: DES
    PCI with implantation of a DES
Active Comparator
Control
  • Device: DES
    PCI with implantation of a DES

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Ervin Mazniku
emazniku@montefiore.org

More Details

NCT ID
NCT03190473
Status
Recruiting
Sponsor
Svelte Medical Systems, Inc.

Study Contact

Betsy Lowry
908-264-2181
blowry@sveltemedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.