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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01247428




Registration number
NCT01247428
Ethics application status
Date submitted
18/11/2010
Date registered
24/11/2010
Date last updated
19/12/2016

Titles & IDs
Public title
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
Scientific title
A First-In-Human Trial of a New Novel DES (MiStent System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries
Secondary ID [1] 0 0
MIS-FIH-2010-01
Universal Trial Number (UTN)
Trial acronym
DESSOLVE-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - MiStent SES

Experimental: 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).


Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Angiographic In-Stent Late Lumen Loss
Timepoint [1] 0 0
8 months
Secondary outcome [1] 0 0
Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)
Timepoint [1] 0 0
240 days
Secondary outcome [2] 0 0
Device Success
Timepoint [2] 0 0
8 hours
Secondary outcome [3] 0 0
Lesion Success
Timepoint [3] 0 0
8 hours
Secondary outcome [4] 0 0
Procedural Success
Timepoint [4] 0 0
8 hours
Secondary outcome [5] 0 0
Total Mortality
Timepoint [5] 0 0
240 days
Secondary outcome [6] 0 0
Total Myocardial Infarction (MI)
Timepoint [6] 0 0
240 days
Secondary outcome [7] 0 0
Clinically-driven Target Lesion Revascularization (TLR) Rates
Timepoint [7] 0 0
240 days
Secondary outcome [8] 0 0
Clinically-driven Target Vessel Revascularization (TVR) Rates
Timepoint [8] 0 0
240 days
Secondary outcome [9] 0 0
Target Vessel Failure (TVF)
Timepoint [9] 0 0
240 days
Secondary outcome [10] 0 0
Target Lesion Failure (TLF)
Timepoint [10] 0 0
240 days
Secondary outcome [11] 0 0
Stent Thrombosis
Timepoint [11] 0 0
240 days
Secondary outcome [12] 0 0
Angiographic Evaluation: In-stent Binary Restenosis
Timepoint [12] 0 0
4 months, 6 months, 8 months
Secondary outcome [13] 0 0
Angiographic Evaluation: In-stent Binary Restenosis
Timepoint [13] 0 0
18 months
Secondary outcome [14] 0 0
Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction
Timepoint [14] 0 0
8 months
Secondary outcome [15] 0 0
IVUS Evaluation: % Neointimal Volume Obstruction
Timepoint [15] 0 0
18 months
Secondary outcome [16] 0 0
Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered
Timepoint [16] 0 0
8 months
Secondary outcome [17] 0 0
OCT Evaluation: % Stent Strut Uncovered
Timepoint [17] 0 0
18 M

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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;
26. Angiographic Assessed prior to stent placement;

* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Aukland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Micell Technologies
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
Trial website
https://clinicaltrials.gov/study/NCT01247428
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
William Wijns, MD
Address 0 0
Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01247428