Paclitaxel-Eluting PTCA-Balloon in Combination with the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease Clnical investigational plan, version 18, 16 october 2006.

Paclitaxel-Eluting PTCA-Balloon in Combination with the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease Clnical investigational plan, version 18, 16 october 2006. - PEPCAD III

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31372

Enrollment

Registered

2007-10-09

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Artherosclerotic cornonary artery disease

Interventions

The patients will be randomized to one of the treatment options: group A: paclitaxel eluting PTCA-balloon in combination with the Coroflex BlueTM stent or, group B: Sirolimus-eluting CypherTM stent d

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Patients with stable or unstable angina or documented ischemia due to a significant lesion in a native coronary artery * Patients eligible for coronary revascularization by means of PCI * Intention to treat one lesion with one stent * Patients must be * 18 years of age * Patients must agree to undergo the 9 months angiographic follow-up * Patients must agree to undergo the 1 and 3 year clinical follow-up * 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 * 2.5 mm and * 3.5 mm and

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Secondary endpoints: Procedural success 30-day complication rate (by phone) Percent stenosis at 9 months Angiographic binary restenosis rate at 9 months Acute and cumulative MACE rate at 9 months Cumulative MACE rate after one years Cumulative MACE rate after three years Indication for premature follow-up	—

Primary

Measure	Time frame
Primary endpoint : Late lumen loss at 9 months. A deviation of +/- 3 months to the 9 months FU is accepted.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)