Clinical trial NCT00232856: A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.
Official title: A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.

Detailed description: This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.

Eligibility criteria: Inclusion Criteria:

1. The patient has an in-stent restenosis of ≥ 60% and \< 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery.
2. The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion.

Exclusion Criteria:

1. Unprotected left main coronary disease with ≥ 50% stenosis;
2. Patient previously treated with brachytherapy in any coronary vessel.
3. Target lesion involves bifurcation including a side branch \>2.5mm in diameter.
4. The patient sustained a recent (\<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.

Primary outcomes:
measure: angiographic in-lesion late loss
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: in-stent mean percent diameter stenosis (%DS)
timeFrame: 6-months post-procedure
measure: i-stent late loss (LL)
timeFrame: 6 months post-procedure
measure: in-lesion binary restenosis
timeFrame: 6-months post-procedure
measure: Target Vessel Revascularization (TVR)
timeFrame: 9-months post-procedure
measure: Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel
timeFrame: 9 months post-procedure
measure: Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization in-hospital
timeFrame: 1, 6, 9 months and, 2 and 3 years post-procedure
measure: occurrence of bleeding
timeFrame: 1, 6, 9 months and, 2 and 3 years post-procedure
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: K.U. Leuven
city: Bad-Krozingen
country: Germany
facility: Herz-zentrum Bad Krozingen
Study officials:
affiliation: Herz-zentrum Bad Krozingen
name: Franz-Josef Neumann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: K.U. Leuven
name: Walter Desmet, MD
role: PRINCIPAL_INVESTIGATOR
References: