Endothelial Function following stenting with Genous vs Drug-Eluting Stents - Vasomotio

• Conditions: Patients with symptomatic ischemic heart disease expressing one or two de novo native coronary artery lesions; MedDRA version: 9.1Level: LLTClassification code 10011078Term: Coronary artery disease

• Registration Number: EUCTR2007-001794-28-NL
• Lead Sponsor: OrbusNeich Medical BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Currently receiving statin therapy for at least 2 weeks prior to the index procedure;
2.18 to 85 years of age;
3.Symptomatic ischemic heart disease (CCS class 1–4, Braunwald class IB, IC, and/or objective evidence of myocardial ischemia);
4.Single de novo lesions; Patients with an additional lesion in another vessel can be included, however, the vasomotion study is to be performed on only one lesion which is identified by the investigator, prior to randomization, as the one which is most suitable for vasomotion study.
5.Target lesion is located in a native coronary artery, which can be covered by one single;
6.Reference vessel diameter ? 2.5 and ? 4.0 mm by visual estimate;
7.Acceptable candidate for coronary artery bypass surgery (CABG);
8.Target lesion stenosis is >50% and <100% (minimum TIMI flow I at the time of the PCI
procedure) (visual estimate);
9.The patient is willing to comply with the specified follow-up evaluation;
10.The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Committee (EC).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Women who are pregnant or women of childbearing potential who do not use adequate contraception;
2.A Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes or Troponin levels are less than twice the Upper Normal Limit;
3.Uncontrolled hypertension or currently treated with three or more hypertensive medications. Patients unable to discontinue beta blockers, calcium antagonists, nitrates, ACE inhibitors or angiotensin II inhibitors for 48 hours prior to the scheduled 6 month angiographic follow-up should not be included.
4.Impaired renal function (creatinine > 3.0 mg/dl or 265 µmol/l);
5.Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC of < 3,000 cells/mm3;
6.Documented or suspected liver disease (including laboratory evidence of hepatitis);
7.Recipient of heart transplant;
8.Any patient who previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-mouse Antibodies (HAMA);
9.Patient with a life expectancy less than the follow-up period (6 months);
10.Known allergies to aspirin, clopidogrel bisulphate (Plavix?) and ticlopidine (Ticlid?), heparin, or stainless steel;
11.Known side-effects (clinically demonstrated by biological tests, elevated CK and liver assessments) to statins and previous attempts to treat side-effects were unsuccessful;
12.Any significant medical condition which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study;
13.Currently participating in an investigational drug or another device study that has not completed the primary endpoint, or subject to inclusion in another investigational drug or another device study during follow-up of this study;
14.Patients currently undergoing chemotherapy or immunosuppressant therapy;
15.Patients with known malignancy(ies).
Angiographic exclusion criteria:
16.Unprotected left main coronary artery disease with ? 50% stenosis;
17.Ostial target lesion;
18.Totally occluded target vessel (TIMI flow 0);
19.Target lesion has excessive tortuousity unsuitable for stent delivery and deployment;
20.Target lesion involves bifurcation class D & type G including a side branch ? 2.5mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require stenting of diseased side branch;
21.Angiographic evidence of thrombus in the target vessel;
22.A significant (> 50%) stenosis proximal or distal to the target lesion;
23.Impaired runoff in the treatment vessel with diffuse distal disease;
24.Left Ventricular ejection fraction ? 30%;
Other exclusion criteria:
25.Pre-treatment with devices other than balloon angioplasty, although direct stenting is allowed;
26.Prior stent within 5mm of target lesion;
27.
Intervention of another lesion within 6 months prior to or after the index procedure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified