Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)

Sponsor

University Hospital, Saarland (Other)

Overall Status

Completed

CT.gov ID

NCT00409981

Collaborator

(none)

Enrollment

Locations

Duration (Months)

11.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The PACCOCATH ISR II study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.

Condition or Disease	Intervention/Treatment	Phase
Coronary Restenosis	Device: paclitaxel coated balloon catheter (device with drug)	Phase 1/Phase 2

Detailed Description

Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR.

Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=56 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, < 30 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)

Study Start Date :

Jul 1, 2004

Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

angiographic late lumen loss []

Secondary Outcome Measures

binary restenosis rate; major adverse cardiac events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years
Clinical evidence of stable or unstable angina or a positive functional study
Single, restenotic lesion in a stented coronary artery (allowed are multiple lesions but only the target lesion is amenable for percutaneous intervention, i.e. no 'staged' procedures involving non-target lesions)
Diameter stenosis > 70% (visual estimate)
Stented segment length < 30 mm
Vessel diameter => 2.5 mm
Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
Signed patient informed consent form
Patients and treating physicians agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol

Exclusion Criteria:

Left ventricular ejection fraction of < 30%
Target lesion/vessel with any of the following characteristics: Clear angiographic calcification in the target lesion or greater than mild calcification in the proximal vessel (minimally radiopaque densities that are discrete and non-linear). Visible thrombus proximal to the lesion.
Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated.
Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy causing the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
Severe chronic renal insufficiency.
Significant gastrointestinal (GI) bleed within the past six months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and/or requires additional anti-platelet and/or anti-coagulation treatment.
Participating in another device or drug study within the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes	Homburg / Saar	Saarland	Germany	66421
2	Kardiologie, Campus Mitte, Charite	Berlin		Germany	10117
3	Kardiologie, Campus Virchow-Klinikum, Charite	Berlin		Germany	13353
4	Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie	Freiburg		Germany	79106
5	I. Medizinische Klinik, Universitaetsklinikum	Mannheim		Germany	68167