PEPCAD DES - Treatment of DES-In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting PTCA Catheter
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- In-Stent Restenosis
- Sponsor
- Klinikum Coburg
- Enrollment
- 120
- Locations
- 8
- Primary Endpoint
- Late lumen loss
- Last Updated
- 14 years ago
Overview
Brief Summary
The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in native coronary arteries with reference diameters between 2.5 mm and ≤ 3.5 mm and lesion lengths ≤ 22 mm. The vessel patency following treatment with SeQuent® Please will be documented in ISR patients that have been treated with the Cypher® or Taxus® drug eluting stent.
Detailed Description
Background information Current treatments for In Stent Restenosis (ISR) are 'uncoated balloon only' angioplasty with conventional balloons (POBA), Bare Metal Stent (BMS) implantations, cutting balloons, rotablation and atherectomy. Their respective results to lower target vessel revascularizations were in part unsatisfactory and often conflicting. Also the temporary use of brachytherapy lead to late lumen loss (LLL) findings in the range from 0.22 ± 0.84 mm. Therefore, brachytherapy to treat ISR has also been abandoned because of the associated delayed endothelialization leading to late thrombosis. The use of drug eluting stents (DES) to treat ISR lowered restenosis rates in the single digit range. Recently, the use of matrix coated paclitaxel-eluting PTCA balloon catheters (SeQuent® Please, Paccocath Technology®, Bayer/Schering \& B.Braun Melsungen AG) was compared to PES in the PEPCAD II trial which showed significantly lower 6-month LLL, 6-month MACE and TVR rates for SeQuent® Please (7.25%) as compared to PES for which the 12-month TVR rate was 19.0% and therefore in agreement with prior studies (ISAR DESIRE). Since these assessments were done in patients with BMS in-stent restenosis, it is of paramount interest to study in-stent restenosis of failed DES implantations since they may cause continued chronic inflammatory responses caused by the non-bioabsorbable polymer in particular once the drug release has ceased.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient Related
- •Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
- •Patients eligible for coronary revascularization by means of PCI
- •Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty, or coronary artery bypass grafting)
- •Patients must be ≥ 18 years of age
- •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 6 months follow-up
- •Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
- •Patients must agree to undergo the 6 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 or other suitable devices. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
Exclusion Criteria
- •Patient Related
- •Patients with acute (\< 24 h) or recent (48 hours) myocardial infarction
- •Patients with unstable angina pectoris (Braunwald class 3)
- •Patients with severe congestive heart failure
- •Patients with severe heart failure NYHA IV
- •Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP and/or fluid challenge)
- •Patients with severe valvular heart disease
- •Women who are pregnant or lactating patients with life expectancy of less than five years or factors making clinical follow-up difficult
- •Patients with another coronary stent previously implanted into the target vessel
- •Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
Outcomes
Primary Outcomes
Late lumen loss
Time Frame: 6 months
Secondary Outcomes
- Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis(3 years)
- Major adverse cardiac event (MACE) rate(30 days)
- Percent in-stent stenosis(6 months)
- Percent in-segment stenosis(6 months)
- In-stent late loss index(6 months)
- Angiographic binary in-stent stenosis rate(6 months)
- In-segment late loss index(6 months)
- Angiographic binary in-segment stenosis rate(6 months)
- Indication for premature follow-up(6 months)
- Type of recurrence (Mehran-Classification)(6 months)
- Target vessel failure(6 months)
- MACE Rate(3 years)