NCT01294748

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
6 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 26, 2014

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 8, 2017

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

February 10, 2011

Results QC Date

February 6, 2014

Last Update Submit

December 15, 2016

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseDrug-eluting StentSirolimus

Outcome Measures

Primary Outcomes (2)

  • 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

    9 months

  • 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.

    9 months

Secondary Outcomes (9)

  • Device Success

    8 hours

  • Lesion Success

    8 hours

  • Procedural Success

    8 hours

  • Total Mortality

    9-months

  • Total Myocardial Infarct (MI)

    9-months

  • +4 more secondary outcomes

Study Arms (2)

MiStent DES

EXPERIMENTAL

The MiStent SES is a sirolimus-eluting absorbable polymer stent for coronary artery revascularization.

Device: MiStent DES

Endeavor DES

ACTIVE COMPARATOR

The Endeavor DES is an everolimus-eluting durable polymer stent for coronary artery revascularization.

Device: Endeavor DES

Interventions

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).

MiStent DES
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).

Endeavor DES

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Cardiovascular Center

Aalst, Belgium

Location

Antwerp Hospital, ZNA Middelheim

Antwerp, Belgium

Location

Brussels University Hospital

Brussels, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Virga Jesse Ziekenhuis

Hasselt, Belgium

Location

KUL Cardiology Gasthuisberg

Leuven, Belgium

Location

Jacques Cartier Hospital

Massy, France

Location

Claude Galien Hospital

Quincy, France

Location

Clinique Pasteur

Toulouse, France

Location

OLV

Amsterdam, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

TweeSteden Ziekenhuis

Tilburg, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Hospital Weezenlanden

Zwolle, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

Mercy Angiography Unit

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Orebro University Hospital

Örebro, Sweden

Location

Royal Sussex Hosp

Brighton, United Kingdom

Location

Papworth Hospital

Cambridge, United Kingdom

Location

Guy's & St. Thomas'

London, United Kingdom

Location

Royal Brompton

London, United Kingdom

Location

University Hospital South Manchester

Manchester, United Kingdom

Location

Norfolk/Norwich UHosp

Norwich, United Kingdom

Location

Southampton UHT

Southampton, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 25044635DERIVED

  • 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.

    PMID: 24801119DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Jeffrey Mifek, VP Clinical Affairs
Organization
Micell Technologies
jmifek@micell.com
919-313-2102

Study Officials

  • William Wijns, MD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

August 1, 2016

Last Updated

February 8, 2017

Results First Posted

March 26, 2014

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(6)NL(5)SE(2)GB(7)NZ(5)FR(3)