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Treatment of Drug-eluting Stent (DES) In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

NCT00998439 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-05-20

No results posted yet for this study

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.

Conditions

  • In-Stent Restenosis

Interventions

DEVICE

SeQuent® Please

* 6 F, 7 F, or 8 F guiding catheters have to be used * after insertion of arterial sheath, apply heparin (7,500-10,000 Units i.a. or i.c. (or 50-100 U/kg body weight)) * additional dose of 5,000 Units (75 U/kg body weight) if procedure lasts for more than one hour * Nitroglycerin (0.2 mg i.c.) prior to first contrast injection * ISR must be predilated with uncoated balloon * balloon diameter shall be 0.5 mm smaller than the Paclitaxel-eluting balloon intended for use * inflation time has to be ≥ 30 sec * select balloon with correct stent diameter to achieve a remaining stenosis of ≤ 10 % * each Paclitaxel-eluting balloon catheter is allowed for single use only * additional inflations and/or aggressive anti-platelet agents for intraluminal defects or haziness * if additional balloon is necessary, only uncoated balloon is permitted to avoid overdosing of drug

DEVICE

SeQuent® II

* 6 F, 7 F, or 8 F guiding catheters have to be used * after insertion of arterial sheath, apply heparin (7,500-10,000 Units i.a. or i.c. (or 50-100 U/kg body weight)) * additional dose of 5,000 Units (75 U/kg body weight) if procedure lasts for more than one hour * Nitroglycerin (0.2 mg i.c.) prior to first contrast injection * ISR must be predilated with uncoated balloon * balloon diameter shall be 0.5 mm smaller than the Paclitaxel-eluting balloon intended for use * inflation time has to be ≥ 30 sec * select balloon with correct stent diameter to achieve a remaining stenosis of ≤ 10 % * each Paclitaxel-eluting balloon catheter is allowed for single use only * additional inflations and/or aggressive anti-platelet agents for intraluminal defects or haziness * if additional balloon is necessary, only uncoated balloon is permitted to avoid overdosing of drug

Sponsors & Collaborators

  • Klinikum Coburg

    lead OTHER

Principal Investigators

  • Harald Rittger, MD · Klinikum Coburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00998439 on ClinicalTrials.gov