PEPCAD III

Paclitaxel-Eluting PTCA-Balloon in combination with the Coroflex Blue Stent (Coroflex DEBlue system) vs the Sirolimus Coated Cypher Stent in the treatment of advanced Coronary Artery Disease.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28432

Enrollment

600

Registered

2008-01-22

Start date

2008-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Coronary Artery Disease

Interventions

The patients will be randomized to one of the treatment options

1. group A: paclitaxeleluting PTCA-balloon in combination with the Coroflex BlueTM stent

2. group B: Sirolimus-eluting CypherTM stent deployment. Diabetes mellitus is expected to have a major impact on the primary endpoint. A stratification for existence or absence of clinically relevant

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with stable or unstable angina or documented ischemia due to a significant lesion in a native coronary artery; 2. Patients eligible for coronary revascularization by means of PCI Intention to treat one lesion with one stent; 3. Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty, or coronary artery bypass grafting); 4. Patients must be ¡Ý 18 years of age; 5. Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 9 months follow-up; 6. Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol; 7. Patients must agree to undergo the 9 months angiographic follow-up; 8. Patients must agree to undergo the 1 and 3 year clinical follow-up; 9. Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter in combination with the Coroflex BlueTM stent or the Sirolimus-eluting CypherTM stent. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. Inclusion Criteria: Lesion Related Significant stenoses in native coronary arteries with nominal stent diameters between ¡Ý 2.5 mm and ¡Ü 3.5 mm and < 24 mm in length.

Exclusion criteria

Exclusion criteria: 1. Unprotected left main; 2. In stent restenosis; 3. Indication for more than one lesion to treat, even as staged procedure; 4. Intended bifurcational stenting; 5. Patients requiring chronic anticoagulation SVG and AG; 6. Acute MI (STEMI, NSTEMI); 7. Cardiogenic shock; 8. Chronical total occlusions; 9. Pregnancy; 10. Patients with stand alone balloon angioplasty, or stent deployment 6 months prior to enrolment into this study.

Design outcomes

Primary

Measure	Time frame
Primary End-Point: The primary end point is defined by the late lumen loss in treated segment (= stent +/- 5 mm) at 9 months from the procedure.	—

Secondary

Measure	Time frame
The secondary end points include: 1. Technical success (Technical success is defined as successful placement and deployment of the stent across the lesion; 2. Procedural success (Procedural success was defined as normal flow (TIMI 3) with a stenosis <50%); 3. 30-day complication rate (from date of intervention); 4. Percent stenosis at 9 months; 5. Angiographic binary restenosis rate at 9 months; 6. Acute and cumulative MACE rate at 9 months; 7. Cumulative MACE rate after one year; 8. Cumulative MACE rate after three years; 9. Indication for premature follow-up; 10. Rate of SAT 30 days and 9 months; 11. TVR (decision CEC); 12. TLR (decision CEC); Major adverse cardiac events (MACE) are defined as cardiac death or death of unknown cause, myocardial infarction ¨C STEMI and NSTEMI (CK 5-fold, CK-MB 3-fold), and ischemia driven premature target lesion revascularization during the follow-up period of three years form the procedure. In-segment refers to the entire stent length plus 5 mm of the native vessel on either side adjacent to the stent. 6	—

Measure

Time frame

The secondary end points include: 1. Technical success (Technical success is defined as successful placement and deployment of the stent across the lesion; 2. Procedural success (Procedural success was defined as normal flow (TIMI 3) with a stenosis <50%); 3. 30-day complication rate (from date of intervention); 4. Percent stenosis at 9 months; 5. Angiographic binary restenosis rate at 9 months; 6. Acute and cumulative MACE rate at 9 months; 7. Cumulative MACE rate after one year; 8. Cumulative MACE rate after three years; 9. Indication for premature follow-up; 10. Rate of SAT 30 days and 9 months; 11. TVR (decision CEC); 12. TLR (decision CEC); Major adverse cardiac events (MACE) are defined as cardiac death or death of unknown cause, myocardial infarction ¨C STEMI and NSTEMI (CK 5-fold, CK-MB 3-fold), and ischemia driven premature target lesion revascularization during the follow-up period of three years form the procedure. In-segment refers to the entire stent length plus 5 mm of the native vessel on either side adjacent to the stent. 6

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Contacts

Public ContactE. Geerligs

VU Medical Center Cardiology 6D 130 de Boelelaan 1117

e.geerligs@vumc.nl+31-204444445

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)