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Study Comparing the MiStent SES Versus the XIENCE EES Stent (DESSOLVE III)

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ClinicalTrials.gov Identifier: NCT02385279
Recruitment Status : Active, not recruiting
First Posted : March 11, 2015
Last Update Posted : August 11, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

Condition or disease Intervention/treatment
Coronary Stenosis Device: MiStent Device: XIENCE EES

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries
Study Start Date : March 2015
Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: MiStent®
Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.
Device: MiStent
Percutaneous Coronary Intervention
Active Comparator: XIENCE EES
Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.
Device: XIENCE EES
Percutaneous Coronary Intervention


Outcome Measures

Primary Outcome Measures :
  1. Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the MISTENT group to the XIENCE group [ Time Frame: 12 months postprocedure ]
    TLF is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel and clinically-indicated target lesion revascularization.


Secondary Outcome Measures :
  1. POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  2. MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR) [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  3. Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  4. DOCE/TLF defined as cardiac death, TV MI or clinically indicated Target Lesion Revascularization (TLR) [ Time Frame: 30 days, 6 months, 2 years, 3 years ]
  5. Mortality [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  6. Myocardial infarction [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  7. Revascularization [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  8. Stent thrombosis rates according to ARC classification [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All comers" patients:

  • Male or female patients 18 years or older;
  • Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
  • The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
  • The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion Criteria:

  • Known pregnancy or breastfeeding at time of randomization;
  • Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • The patient is unwilling/ not able to return for outpatient clinic at 1 month and 12 months follow-up.
  • Currently participating in another trial and not yet at its primary endpoint.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385279


Locations
France
Research Center Corbeil
Corbeil, France
Research Center Nimes
Nimes, France
Research Center Poitiers
Poitiers, France
Germany
Research Center Jena
Jena, Germany
Research Center Leipzig
Leipzig, Germany
Research Center Munster
Munster, Germany
Research Center Ulm
Ulm, Germany
Research Center Wiesbaden
Wiesbaden, Germany
Netherlands
Research Center Amersfoort
Amersfoort, Netherlands
Research Center Amsterdam
Amsterdam, Netherlands
Tergooi
Blaricum, Netherlands
Research Center Emmen
Emmen, Netherlands
Research Center Leeuwarden
Leeuwarden, Netherlands
Research Center Nijmegen
Nijmegen, Netherlands
Research Center Venlo
Venlo, Netherlands
Poland
Research Center Belchatow
Belchatow, Poland
Research Center Bielsko-Biala
Bielsko-Biala, Poland
Research center Chrzanow
Chrzanow, Poland
Research Center Tychy
Tychy, Poland
Research Center Zgierz
Zgierz, Poland
Sponsors and Collaborators
ECRI bv
Micell Technologies
Stentys
Investigators
Study Director: Gerrit-Anne van Es ECRI bv
Principal Investigator: P. W. Serruys, Prof. MD. International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom
Principal Investigator: W Wijns, Prof. MD. Hartcenter, OLV Aalst, Belgium
Principal Investigator: R. de Winter, Prof. MD. Academisch Medisch Centrum, Amsterdam, The Netherlands
More Information

Responsible Party: ECRI bv
ClinicalTrials.gov Identifier: NCT02385279     History of Changes
Other Study ID Numbers: ECRI-005
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by ECRI bv:
CAD
ACS
All comers
PCI

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs