First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease

NCT01247428 | Completed Phase 2 Results DMC

• 1 other identifier: MIS-FIH-2010-01
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 5

Brief Summary

The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Drug-eluting Stent; Sirolimus

Outcome Measures

Primary Outcomes (1)

• Angiographic In-Stent Late Lumen Loss

  In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.

  8 months

Secondary Outcomes (17)

• Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)

  240 days

• Device Success

  8 hours

• Lesion Success

  8 hours

• Procedural Success

  8 hours

• Total Mortality

  240 days

Study Arms (1)

MiStent SES

EXPERIMENTAL

The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).

Device: MiStent SES

Interventions

MiStent SES DEVICE

The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).

MiStent SES

Eligibility Criteria

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

You may qualify if:

• Male/female patients 18-85 years;
• Stable or unstable angina pectoris, ischemia, or silent ischemia;
• Planned single, de novo, types A, B1 and B2 coronary lesions;
• Target lesion located in a native coronary artery;
• Target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm long stent;
• Target lesion \>50% diameter stenosis;
• Patients eligible for percutaneous coronary intervention (PCI);
• Acceptable candidate for myocardial revascularization surgery;
• A patient may have one additional critical non-target lesion.
• The patient will provide written informed consent.

You may not qualify if:

• Female of childbearing potential not on some form of birth control with a confirmed negative pregnancy test at baseline;
• Recent Q-wave myocardial infarction occurred \<72 hours prior to the index procedure. Recent myocardial infarction with elevated levels of cardiac markers;
• Left ventricular ejection fraction \<30%;
• Patients in cardiogenic shock;
• Cerebrovascular accident or transient ischemic attack within 6 months;
• Active GI bleed within three months;
• Any prior true anaphylactic reaction to contrast agents;
• Patient receiving/scheduled to receive chemotherapy within 30-days before or after the index procedure;
• Patient is receiving immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease;
• Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L);
• Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³;
• White blood cell count \<3,000 cells/mm3;
• Hepatic disease;
• Heart transplant recipient;
• Known contraindication to dual antiplatelet therapy;

Sponsors & Collaborators

• Micell Technologies: lead

Study Sites (5)

St. Vincent's Hospital Melbourne

Melbourne, Australia

Location

Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)

Aalst, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Auckland City Hospital

Auckland, 1032, New Zealand

Location

Mercy Angiography Unit - Mercy Hospital

Aukland, 1032, New Zealand

Location

Related Publications (2)

• Ormiston J, Webster M, Stewart J, Vrolix M, Whitbourn R, Donohoe D, Knape C, Lansky A, Attizzani GF, Fitzgerald P, Kandzari DE, Wijns W. First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I Trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries). JACC Cardiovasc Interv. 2013 Oct;6(10):1026-34. doi: 10.1016/j.jcin.2013.05.013. Epub 2013 Sep 18.

  PMID: 24055443 RESULT

• Attizzani GF, Bezerra HG, Ormiston J, Wang W, Donohoe D, Wijns W, Costa MA. Serial assessment by optical coherence tomography of early and late vascular responses after implantation of an absorbable-coating Sirolimus-Eluting stent (from the first-in-human DESSOLVE I trial). Am J Cardiol. 2013 Nov 15;112(10):1557-64. doi: 10.1016/j.amjcard.2013.07.013. Epub 2013 Aug 29.

  PMID: 23992957 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dennis Donohoe, MD, Chief Medical Advisor
• Organization: Micell Technologies

ddonohoeconsult@gmail.com

919-313-2102

Study Officials

• William Wijns, MD

  Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)

  PRINCIPAL INVESTIGATOR

• John Ormiston, MD

  Mercy Angiography Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 24, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2016
• Last Updated: December 19, 2016
• Results First Posted: June 12, 2014

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); BE (2); AU (1)