HEALING IIB - Healthy Endothelial Accelerated Lining Inhibits Neointimal GrowthA Clinical, Multi-center, Prospective, non-Randomized Study - HEALING IIb

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

1.18 to 85 years of age;
2.Symptomatic ischemic heart disease (CCS class 1–4, Braunwald class IB, IC, and/or objective evidence of myocardial ischemia);
3.Treatment of 1 or 2 de novo lesions;
4.Target lesion(s) is(are) located in a native coronary artery, which can be covered by one single stent of maximum 33 mm; The coronary artery lesion should be ?27 mm in length (a margin of 3mm proximal and 3mm distal is recommended) and should be entirely covered by one single Genous Bio-engineered R stentTM . If predilation of the lesion is visually deemed necessary it should be performed prior to measuring the length of the lesion.
5.Reference vessel diameter ? 2.5 and ? 3.75 mm by visual estimate;
6.Acceptable candidate for coronary artery bypass surgery (CABG);
7.Target lesion stenosis is >50% and <100% (minimum TIMI flow I at the time of the PCI
procedure) (visual estimate);
8.The patient is willing to comply with the specified follow-up evaluation;
9.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

General 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.Impaired renal function (creatinine > 3.0 mg/dl or 265 µmol/l);
4.Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC of < 3,000 cells/mm3;
5.Documented or suspected liver disease (including laboratory evidence of hepatitis);
6.Recipient of heart transplant;
7.Any patient who previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-mouse Antibodies (HAMA);
8.Patient with a life expectancy less than the follow-up period (5 years);
9.Known allergies to aspirin, clopidogrel bisulphate (Plavix?) and ticlopidine (Ticlid?), heparin, or stainless steel;
10.Known side-effects (clinically demonstrated by biological tests, elevated CK and liver assessments) to statins and previous attempts to treat side-effects were unsuccessful;
11.Any significant medical condition which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study;
12.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;
13.Patients currently undergoing chemotherapy or immunosuppressant therapy;
14.Patients with known malignancy(ies).

Angiographic exclusion criteria:
15.Unprotected left main coronary artery disease with ? 50% stenosis;
16.Ostial target lesion;
17.Totally occluded target vessel (TIMI flow 0);
18.Target lesion has excessive tortuousity unsuitable for stent delivery and deployment;
19.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;
20.Angiographic evidence of thrombus in the target vessel;
21.A significant (> 50%) stenosis proximal or distal to the target lesion;
22.Impaired runoff in the treatment vessel with diffuse distal disease;
23.Ejection fraction ? 30%;
24.Pre-treatment with devices other than balloon angioplasty, although direct stenting is allowed;
25.Prior stent within 5mm of target lesion;
26.Intervention of another lesion within 6 months before or within the scheduled angiographic follow-up of the index procedure.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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