The aim of the study is to assess the safety and efficacy of thePaclitaxel-eluting SeQuent Please S stent system in the treatmentof stenoses in native coronary arteries with nominal stentdiameters between * 2.5 mm and * 3.5 mm and < 24 mm…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint :
Late lumen loss at 9 months. A deviation of +/- 3 months to the 9
months FU is accepted.
Secondary outcome
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
Background summary
Background information
The incidence of in-stent restenosis after percutaneous coronary intervention
varies
between 5 and 35% after bare metal stenting and is as high as 19% after the
implantation of a drug-eluting stent in patients at moderate risk. Restenosis
due to
neointimal hyperplasia is a slow process, suggesting that therapeutic local drug
administration would need to be prolonged to be beneficial. Stent-based local
drug
delivery provides sustained drug release using special release technologies like
polymer coating. However, cell culture experiments indicate that even brief
contact
between vascular smooth muscle cells and lipophilic taxane compounds can inhibit
vascular smooth muscle cell proliferation for a long period. In experiments in
swine,
intracoronary delivery of paclitaxel by contrast media or by a drug-coated
balloon
catheter was found to result in vascular tissue concentrations capable of
producing
antiproliferative effects, thus leading to a significant reduction in neointimal
proliferation. In these animal studies, the most pronounced reduction of
neointimal
formation was seen with paclitaxel-coated balloon catheters.
Study objective
The aim of the study is to assess the safety and efficacy of the
Paclitaxel-eluting SeQuent Please S stent system in the treatment
of stenoses in native coronary arteries with nominal stent
diameters between * 2.5 mm and * 3.5 mm and < 24 mm in
length for procedural success and preservation of vessel patency
in comparison to the Sirolimus-eluting CypherTM stent.
Study design
Study Design
The PEPCAD III study is a prospective, randomized, multi-center, two-armed
phase-II
study assessing the 30 days, 9 months, and 1 and 3 year outcome of the
Paclitaxeleluting
PTCA balloon in combination with the Coroflex BlueTM stent in comparison to
the Sirolimus-eluting CypherTM stent conducted in Europe.
Intervention
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 deployment.
angiographic follow-up scheduled at 9 months for all patients.
Study burden and risks
The most burdening will be the heartcatheterization at 9 months, less burdening
will be the bloodsampling.
Study risks can be associated with possible side effects of Paclitaxel delivery:
- Allergic or immunological reaction to drugs or to the balloon coating
- Alopecia
- Anaemia
- Blood transfusion
- Gastro-intestinal tract impairment
- Haematological dyscrasia (incl. leukocytopenia, neutropenia, thrombocytopenia)
- Abnormal liver enzyme values
- Histological changes in the vascular wall, incl. inflammation, cell damage, or
necrosis
- Myalgia / arthralgia
- Peripheral neuropathy
Side effects yet unknown cannot be ruled out.
Sieversufer 8
D-12359 Berlin
DE
Sieversufer 8
D-12359 Berlin
DE
Listed location countries
Age
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 < 24 mm in length
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17172.029.07 |