Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03716102
Other study ID # IP-18-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 21, 2018
Est. completion date July 15, 2021

Study information

Verified date June 2020
Source Svelte Medical Systems, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.


Description:

This is a prospective, open, non-randomized, study involving two (2) centers in the United States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12
Est. completion date July 15, 2021
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject is an eligible candidate for PCI

- Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia

- Subject is an acceptable candidate for CABG

- Subject has = 3 de novo target lesions in = 2 native coronary artery vessels, with = 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 RVD = 2.25mm and = 4.00mm

Exclusion Criteria:

- Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina

- Subject's target lesion(s) is located in the left main coronary artery

- Subject's target lesion(s) is located within 3mm of the origin of the LAD or LCX coronary artery

- Subject's target lesion(s) is located within a SVG or an arterial graft

- Subject's target lesion(s) will be accessed via SVG or arterial graft

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PCI with implantation with DES
PCI with implantation with DES

Locations

Country Name City State
United States Northern Michigan Hospital d.b.a McLaren Northern Michigan Petoskey Michigan
United States Scottsdale Healthcare Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Svelte Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed blood concentration (Cmax) Up to 30 days
Primary Time to reach maximum blood concentration (tmax) Up to 30 days
Primary Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t) Up to 30 days
Primary Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-8) Up to 30 days
Primary Terminal phase half-life (t1/2) Up to 30 days
Primary Apparent total blood clearance (CL/F) Up to 30 days
Primary Apparent volume of distribution (Vd/F) Up to 30 days
Secondary Target Vessel Failure (TVF) 6 months, 12 months, 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT05412927 - AngelMed Guardian® System PMA Post Approval Study
Completed NCT02750579 - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? N/A
Completed NCT04102410 - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients N/A
Enrolling by invitation NCT03342131 - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome N/A
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation NCT04676100 - International CR Registry
Completed NCT03590535 - 5th Generation cTnT in ED ACS
Recruiting NCT05437900 - INSIGHTFUL-FFR Clinical Trial Phase 4
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated NCT04316481 - IDE-ALERTS Continued Access Study N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT04852146 - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Completed NCT02944123 - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR) Phase 3
Completed NCT04077229 - Piloting Text Messages to Promote Positive Affect and Physical Activity N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Active, not recruiting NCT02922140 - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit N/A
Completed NCT02673437 - Rivaroxaban ACS Specialist Cohort Event Monitoring Study