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

NCT ID: NCT01247428

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-03-31

Brief Summary

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

Detailed Description

The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions < 20 mm in length in the native coronary arteries with reference vessel diameters between 2.5 mm and 3.5 mm.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Drug-eluting Stent; Sirolimus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MiStent SES

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

Group Type: EXPERIMENTAL

MiStent SES

Intervention Type: 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).

Interventions

MiStent SES

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male/female patients 18-85 years;

2. Stable or unstable angina pectoris, ischemia, or silent ischemia;

3. Planned single, de novo, types A, B1 and B2 coronary lesions;

4. Target lesion located in a native coronary artery;

5. Target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm long stent;

6. Target lesion >50% diameter stenosis;

7. Patients eligible for percutaneous coronary intervention (PCI);

8. Acceptable candidate for myocardial revascularization surgery;

9. A patient may have one additional critical non-target lesion.

10. The patient will provide written informed consent.

Exclusion Criteria

1. Female of childbearing potential not on some form of birth control with a confirmed negative pregnancy test at baseline;

2. Recent Q-wave myocardial infarction occurred <72 hours prior to the index procedure. Recent myocardial infarction with elevated levels of cardiac markers;

3. Left ventricular ejection fraction <30%;

4. Patients in cardiogenic shock;

5. Cerebrovascular accident or transient ischemic attack within 6 months;

6. Active GI bleed within three months;

7. Any prior true anaphylactic reaction to contrast agents;

8. Patient receiving/scheduled to receive chemotherapy within 30-days before or after the index procedure;

9. Patient is receiving immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease;

10. Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);

11. Platelet count <100,000 cells/mm³ or >700,000 cells/mm³;

12. White blood cell count <3,000 cells/mm3;

13. Hepatic disease;

14. Heart transplant recipient;

15. Known contraindication to dual antiplatelet therapy;

16. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin, and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient);

17. Life expectancy <12 months;

18. Any major medical condition that may interfere with the optimal participation of the patient in this study;

19. Patient is currently participating/planning to participate in an investigational drug or another device study prior to completing 12-months follow-up;

20. Target vessel(s) has been treated within 10 mm proximal or distal to target lesion with any type of PCI within a year prior to index procedure;

21. Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter prior to stent placement;

22. Previous coronary intravascular brachytherapy;

23. Planned coronary angioplasty or coronary artery bypass grafting (CABG)in the first 9 months after the index procedure;

24. Prior PCI of a non-target vessel must be at least 30 days prior to study enrollment;

25. The intent to direct stent the target lesion;

• In-stent restenotic target lesion;
• More than one lesion requiring treatment in the target vessel;
• Target vessel diameter <2.5 mm or >3.5 mm;
• Target lesion not amenable to treatment with a 23 mm long stent;
• Unprotected coronary artery branch lesion (≥50% DS);
• Target lesion located in a surgical bypass graft;
• Total vessel occlusion;
• Target lesion with ostial location;
• Target lesion located in a lateral branch bifurcation >2.5mm or requiring lateral branch stenting;
• Calcified target lesion that anticipates unsuccessful/impracticable predilation;
• Target vessel excessive tortuosity or proximal angulation (>90 degrees);
• Thrombus present in target vessel;
• More than one non-target critical lesion;

Non-target lesion to be treated during the index procedure meets any of the following criteria:

• Within the target vessel;
• Within a bypass graft;
• Left main location;
• Chronic total occlusion;
• Involves a complex bifurcation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Micell Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Wijns, MD

Role: PRINCIPAL_INVESTIGATOR

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

John Ormiston, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Angiography Unit

Locations

St. Vincent's Hospital Melbourne

Melbourne, , Australia

Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)

Aalst, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

Auckland City Hospital

Auckland, , New Zealand

Mercy Angiography Unit - Mercy Hospital

Aukland, , New Zealand

Countries

Australia; Belgium; New Zealand

References

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.

Reference Type: RESULT

PMID: 24055443 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23992957 (View on PubMed)

Other Identifiers

MIS-FIH-2010-01

Identifier Type: -

Identifier Source: org_study_id