Vascular Healing After Deployment of Titanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Everolimus-Eluting Stent

Acute Coronary Syndrome Clinical Trial

— TIDES-OCT  

Official title:

A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 2 Months After Deployment of TItanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Drug-Eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280720
• Other study ID #: SA-006
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2014
• Last updated: October 30, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: October 2014
• Source: The Hospital District of Satakunta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Institutional review board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.

1. Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the index procedure.

2. Comparison of intravascular coronary flow reserve measurement to non-invasive transthoracic echocardiography-derived coronary flow reserve measurement.

3. Comparison of epicardial vasodilation to coronary microcirculatory vasodilation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age >18 and <80 years

2. STEMI or NSTEMI (assumed by investigator to be type 1 myocardial infarction, according to universal definitions of MI; EHJ 2007; 28(20):2525-38); or unstable angina (clinical symptoms of chest pain, ecg suggestive of reversible ischemia)

3. Patient is willing to comply with specified follow-up evaluations

4. Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics committee or Institutional Review Board

5. Single de novo or non-stented restenosis lesion

6. Patients with two-vessel disease may have undergone successful treatment of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment

7. Target lesion (maximum 20 mm length by visual estimation) to be covered by a single stent of maximum 23mm length

8. Reference vessel diameter must be >2.5mm and <4.0mm by visual estimate.

9. The vessel diameter should be measured after pre-dilation procedure and after intracoronary nitroglycerin if vasospasm is suspected

10. Target lesion >50% and <100% stenosed by visual estimate

Exclusion Criteria:

1. Pre-existing diagnosis of diabetes irrespective of its type

2. Impaired renal function (serum creatinine >177micromol/l) or on dialysis

3. Platelet count < 10 e5 cells/mm3

4. Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated

5. Patient has received organ transplant or is on a waiting list for any organ transplant

6. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/prasugrel, stainless steel alloy, or contrast agent that cannot be adequately pre-medicated

7. Patient presents with cardiogenic shock

8. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study

9. Currently participating in another intestigational drug or device study

10. Unprotected left main disease

11. Ostial target lesions

12. Chronic total occlusion

13. Calcified target lesions that cannot be adequately pre-dilated

14. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment

15. Target lesion involving bifurcation with a side branch larger than 2.0mm in diameter

16. A >30% stenosis proximal or distal to the target lesion that cannot be covered with the same stent

17. Diffuse distal disease

18. Prior stent in the target vessel

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Procedure:
• Stenting using Optimax™

• Stenting using PROMUS Element™ Plus

Locations

Country	Name	City	State
Finland	Kokkola Central Hospital	Kokkola
Finland	Heart Center, Kuopio University Hospital	Kuopio
Finland	Heart Center, Satakunta Central Hospital	Pori
Finland	Heart Center, Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital District of Satakunta

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of uncovered struts		2 months	No
Secondary	Coronary flow reserve		2 months	No