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Coronary Artery DiseasePhase 2DESSOLVE-IINCT01294748

Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease

A Phase 2 study testing MiStent DES and Endeavor DES in people with Coronary Artery Disease, run by Micell Technologies at 28 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The DESSOLVE II 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 in the native coronary arteries. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
MiStent DES and Endeavor DES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
28 sitesin 6 countries
Study dates
Feb 2011to Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤85 years;
  • Stable/unstable angina pectoris (Class I-IV), documented ischemia/silent ischemia;
  • Planned single, de novo, types A, B1 or B2 coronary lesions;
  • Target lesion located in a native coronary artery;
  • Target lesion in vessel ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a 30 mm long stent;
  • Target lesion with >50% diameter stenosis;
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  • Recent Q-wave (>72 hours) or non-Q-wave myocardial infarction;
  • Patients eligible for PCI;
  • Candidate for CABG ;
  • A patient may have one additional critical non-target lesion.
  • Patient capable of providing informed consent and is willing to comply with all study requirements.

Who cannot join

  • Female patients of childbearing potential who do not have a confirmed negative pregnancy test at baseline and are not on some form of birth control;
  • Recent Q-wave MI < 72 hours prior to the index procedure.
  • Recent Q- or non-Q-wave MI with still elevated levels of cardiac markers (e.g. CK; and CK-MB if the CK is elevated);
  • LVEF <30% (within the previous 6-months);
  • Patients in cardiogenic shock;
  • CVA or TIA within the past 6 months;
Show all 47Show fewer
  • Active GI bleeding within past 3 months;
  • Any prior anaphylactic reaction to contrast agents;
  • Chemotherapy within 30-days before or after the index procedure;
  • Receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or 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 DAPT;
  • Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin and Angiomax (bivalirudin), and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient);
  • Life expectancy less than 12 months;
  • Any major medical condition that may interfere with participation in this study;
  • Patient is currently participating in an investigational drug or another device study and has not completed the follow-up to the primary endpoint, or the patient is planning on participating prior to completing 12-months follow-up;
  • Target vessel has been treated within 10 mm proximal or distal to target lesion with any type of PCI or within a year prior to index procedure;
  • 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;
  • Patient previously treated at any time with brachytherapy;
  • Planned coronary angioplasty or CABG in the first 9 months after the index procedure or any other planned intervention within 30-days post index procedure;
  • Prior PCI of a non-target vessel must be at least 14 days prior to study enrollment;
  • The intent to direct stent the target lesion;
  • Angiographic Exclusion Criteria:
  • In-stent restenotic 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;
  • Long target lesion not amenable to treatment with up to a 30 mm long stent;
  • Left main critical disease (≥50% DS);
  • Target lesion is located in a surgical bypass graft;
  • Total target vessel occlusion (TIMI flow grade 0-1);
  • Target lesion ostial location;
  • Target lesion at bifurcation involving side branch >2.5 mm or lateral branch that also requires stenting;
  • Calcified target lesion that anticipates unsuccessful/impracticable predilation;
  • Target vessel with excessive tortuosity or proximal angulation;
  • 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:
  • Located within the target vessel;
  • Located within a bypass graft ;
  • Left main location;
  • Chronic total occlusion
  • Involves a complex bifurcation.

Trial locations and contacts

28 sites in 6 countries.

28 sites in 6 countries

United Kingdom7 sites

  • Royal Sussex Hosp

    Brighton

  • Papworth Hospital

    Cambridge

  • Guy's & St. Thomas'

    London

  • Royal Brompton

    London

  • University Hospital South Manchester

    Manchester

  • Norfolk/Norwich UHosp

    Norwich

  • Southampton UHT

    Southampton

Other trials in United Kingdom

Belgium6 sites

  • Cardiovascular Center

    Aalst

  • Antwerp Hospital, ZNA Middelheim

    Antwerp

  • Brussels University Hospital

    Brussels

  • Ziekenhuis Oost-Limburg

    Genk

  • Virga Jesse Ziekenhuis

    Hasselt

  • KUL Cardiology Gasthuisberg

    Leuven

Other trials in Belgium

Netherlands5 sites

  • OLV

    Amsterdam

  • St. Antonius Ziekenhuis

    Nieuwegein

  • TweeSteden Ziekenhuis

    Tilburg

  • UMC Utrecht

    Utrecht

  • Hospital Weezenlanden

    Zwolle

Other trials in Netherlands

New Zealand5 sites

  • Auckland City Hospital

    Auckland

  • Mercy Angiography Unit

    Auckland

  • Christchurch Hospital

    Christchurch

  • Dunedin Hospital

    Dunedin

  • Wellington Hospital

    Wellington

Other trials in New Zealand

France3 sites

  • Jacques Cartier Hospital

    Massy

  • Claude Galien Hospital

    Quincy

  • Clinique Pasteur

    Toulouse

Other trials in France

Sweden2 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Orebro University Hospital

    Örebro

Other trials in Sweden

About this study

Official title: Clinical Investigation of a DES (MiStent™ System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in Native Coronary Arteries.

The DESSOLVE II 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 in the native coronary arteries.

Read the detailed description

The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent as compared to the Endeavor DES for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions in the native coronary arteries.

Being tested
MiStent DES, Endeavor DES
Keywords
Coronary Artery Disease, Drug-eluting Stent, Sirolimus
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiStent DESDevice

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

  • Endeavor DESDevice

    The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).

Study groups in NCT01294748
Study groupRoleWhat they receive
MiStent DESExperimentalThe MiStent SES is a sirolimus-eluting absorbable polymer stent for coronary artery revascularization.
Receives: Device: MiStent DES
Endeavor DESActive comparatorThe Endeavor DES is an everolimus-eluting durable polymer stent for coronary artery revascularization.
Receives: Device: Endeavor DES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-Stent Late Lumen Loss

    Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up

    Measured: 9 months

  2. Major Adverse Cardiac Events (MACE)

    Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days.

    Measured: 9 months

Secondary outcomes (9)

  1. Device Success

    Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.

    Measured: 8 hours

  2. Lesion Success

    Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.

    Measured: 8 hours

  3. Procedural Success

    Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, MI or repeat revascularization of the target lesion pre-hospital discharge.

    Measured: 8 hours

  4. Total Mortality

    Measured: 9-months

  5. Total Myocardial Infarct (MI)

    1. Q-wave MI (QWMI): requires one of the following criteria: development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x ULN elevation of CK levels; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.
    2. Non-Q-wave MI (NQWMI):the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels (≥3 times ULN) in the absence of new pathologic Q waves.
    3. Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation >3xULN within 48 hours post -PCI, with a normal CK-MB at baseline.

    Measured: 9-months

  6. Clinically-driven Target Lesion Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself.

    Measured: 9-months

  7. Target Vessel Failure (TVF)

    Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization

    Measured: 9-months

  8. Target Lesion Failure (TLF)

    Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization

    Measured: 9-months

  9. Stent Thrombosis (Definite/Probable)

    The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure

    Measured: 9-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionJun 2012
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01294748
Sponsor's protocol ID
MIS-CEM-2010-02
Acronym
DESSOLVE-II
Status last verified
Dec 2016
First submitted
10 Feb 2011
Last updated
8 Feb 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Rusinaru D, Vrolix M, Verheye S, Chowdhary S, Schoors D, Di Mario C, Desmet W, Donohoe DJ, Ormiston JA, Knape C, Bezerra H, Lansky A, Wijns W; DESSOLVE II Investigators. Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study. Catheter Cardiovasc Interv. 2015 Dec 1;86(7):1141-50. doi: 10.1002/ccd.25610. Epub 2015 Sep 22.

    PubMed 25044635

  • Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, Benit E, Donohoe D, Knape C, Attizzani GF, Lansky AJ, Ormiston J; DESSOLVE II Investigators. Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. EuroIntervention. 2015 Apr;10(12):1383-90. doi: 10.4244/EIJY14M05_03.

    PubMed 24801119

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MiStent DES and Endeavor DES in people with Coronary Artery Disease, run by Micell Technologies at 28 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United Kingdom, Belgium, Netherlands, New Zealand, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-Stent Late Lumen Loss (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01294748, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.

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